Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20250101 - 20251231
No. 601 - 700
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 601 | 25070208 |
US |
56 | 2 |
General physical health deterioration, Device infusion issue, Drug dose omission by device, Device alarm issue, |
||||
| 602 | 25070482 |
US |
48 | 2 |
Drug dose omission by device, Device material issue, |
||||
SOMATROPIN, TOPIRAMATE, LEVOTHYROXINE, |
||||
| 603 | 25070483 |
US |
13 | 1 |
Drug dose omission by device, Device use issue, Device mechanical issue, Device leakage, Device information output issue, |
||||
SOMATROPIN, |
||||
| 604 | 25070866 |
US |
77 | 2 |
Injection site indentation, Blood glucose increased, Drug dose omission by device, Device mechanical issue, Device use issue, |
||||
INSULIN LISPRO, INSULIN LISPRO, |
||||
| 605 | 25071277 |
AR |
24 | 2 |
Drug dose omission by device, Device power source issue, |
||||
SOMATROPIN, |
||||
| 606 | 25071441 |
US |
74 | 2 |
Cough, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 607 | 25071445 |
US |
66 | 2 |
Spinal decompression, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 608 | 25061471 |
US |
2 | |
Drug dose omission by device, Product delivery mechanism issue, Product availability issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 609 | 25061625 |
US |
69 | 2 |
Visual impairment, Device difficult to use, Wrong technique in product usage process, Drug dose omission by device, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 610 | 25062237 |
US |
78 | 2 |
Dementia, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 611 | 25062333 |
US |
79 | 2 |
Dementia, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 612 | 25062490 |
US |
83 | 1 |
Pain in extremity, Myalgia, Visual impairment, Device difficult to use, Wrong technique in product usage process, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 613 | 25062684 |
US |
||
Adverse event, Sleep disorder, Respiratory syncytial virus infection, Throat irritation, Drug dose omission by device, Product container seal issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, BENZONATATE, PREDNISONE, EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE, ATENOLOL, LOSARTAN, PITAVASTATIN CALCIUM, AMLODIPINE, |
||||
| 614 | 25062943 |
US |
67 | |
Dyspnoea, Gait inability, Drug dose omission by device, Wrong technique in product usage process, Wrong technique in device usage process, Device deposit issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, AMLODIPINE, CARVEDILOL, |
||||
| 615 | 25063028 |
US |
39 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, MONTELUKAST SODIUM, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, SERTRALINE HYDROCHLORIDE, |
||||
| 616 | 25063103 |
US |
91 | 1 |
Unevaluable event, Cardiac failure congestive, Drug dose omission by device, Device difficult to use, Rehabilitation therapy, |
||||
EVOLOCUMAB, |
||||
| 617 | 25063139 |
US |
61 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 618 | 25063162 |
US |
||
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 619 | 25063197 |
US |
79 | |
Loss of personal independence in daily activities, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 620 | 25063230 |
US |
||
Dyspnoea, Wrong technique in product usage process, Product use in unapproved indication, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 621 | 25063297 |
US |
32 | |
Drug dose omission by device, Wrong technique in device usage process, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, APIXABAN, |
||||
| 622 | 25063713 |
IT |
10 | 1 |
Device difficult to use, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 623 | 25063834 |
GB |
14 | 2 |
Drug dose omission by device, Device mechanical issue, Device defective, Expired device used, |
||||
SOMATROPIN, |
||||
| 624 | 25063862 |
US |
2 | 1 |
Drug dose omission by device, Device defective, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 625 | 25064154 |
US |
5 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 626 | 25064156 |
US |
13 | 1 |
Drug dose omission by device, Device use issue, Device mechanical issue, Device defective, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 627 | 25064157 |
US |
10 | 1 |
Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 628 | 25064159 |
US |
14 | 1 |
Device issue, Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 629 | 25064160 |
US |
8 | 1 |
Drug dose omission by device, Device breakage, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 630 | 25064385 |
US |
17 | 1 |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 631 | 25064434 |
US |
16 | 1 |
Device malfunction, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, BENZOYL PEROXIDE, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN, |
||||
| 632 | 25064566 |
US |
38 | 2 |
Accidental exposure to product, Device difficult to use, Wrong technique in product usage process, Drug dose omission by device, Anxiety, Maternal exposure during pregnancy, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 633 | 25064656 |
US |
9 | 1 |
Drug dose omission by device, Device use error, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 634 | 25064658 |
CO |
10 | 2 |
Device breakage, Drug dose omission by device, Off label use, |
||||
SOMATROPIN, |
||||
| 635 | 25064870 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 636 | 25064885 |
US |
||
Drug dose omission by device, Device delivery system issue, Wrong technique in product usage process, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, TAMSULOSIN HYDROCHLORIDE, FINASTERIDE, |
||||
| 637 | 25064887 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 638 | 25064907 |
US |
2 | |
Drug dose omission by device, Product use issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 639 | 25065026 |
GR |
1 | |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 640 | 25065036 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 641 | 25065318 |
US |
27 | 2 |
Device malfunction, Needle issue, Device dispensing error, Device leakage, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 642 | 25065719 |
CN |
||
Drug dose omission by device, Condition aggravated, |
||||
| 643 | 25065763 |
US |
47 | 2 |
Product communication issue, Device difficult to use, Drug dose omission by device, Foot fracture, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 644 | 25065804 |
IT |
10 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 645 | 25056242 |
US |
78 | 2 |
Blood triglycerides increased, Product administration error, Device difficult to use, Drug dose omission by device, Product communication issue, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 646 | 25056245 |
US |
1 | |
Injection site pain, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 647 | 25056252 |
US |
72 | 2 |
Injection site indentation, Injury associated with device, Accidental exposure to product, Device difficult to use, Device use error, Drug dose omission by device, Injection site pain, |
||||
EVOLOCUMAB, |
||||
| 648 | 25056282 |
US |
63 | 2 |
Wrong technique in product usage process, Device difficult to use, Drug dose omission by device, Injection site pain, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 649 | 25056515 |
US |
||
Lung disorder, Device delivery system issue, Incorrect dose administered by device, Incorrect dose administered, Wrong technique in product usage process, Product communication issue, Wrong technique in device usage process, Drug dose omission by device, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 650 | 25056819 |
US |
73 | 1 |
Device difficult to use, Drug dose omission by device, Nasopharyngitis, |
||||
EVOLOCUMAB, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, DUPILUMAB, GUAIFENESIN, |
||||
| 651 | 25056832 |
US |
21 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 652 | 25056908 |
US |
52 | 2 |
Injection site pain, Device difficult to use, Device use error, Drug dose omission by device, Wrong technique in product usage process, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 653 | 25057114 |
US |
87 | |
Wrong technique in device usage process, Drug dose omission by device, Device difficult to use, No adverse event, |
||||
TIOTROPIUM BROMIDE, BUDESONIDE, ARFORMOTEROL TARTRATE, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 654 | 25057165 |
US |
1 | |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 655 | 25057508 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 656 | 25057517 |
US |
80 | 2 |
Cerebrovascular accident, Device difficult to use, Drug dose omission by device, Nervousness, Hypertension, Blood cholesterol increased, |
||||
EVOLOCUMAB, |
||||
| 657 | 25057540 |
TR |
24 | 1 |
Therapy interrupted, Drug dose omission by device, Product availability issue, |
||||
SOMATROPIN, |
||||
| 658 | 25057544 |
US |
2 | |
Drug dose omission by device, Product delivery mechanism issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, AMOXICILLIN, GABAPENTIN, SERTRALINE, |
||||
| 659 | 25057587 |
US |
46 | |
Nasopharyngitis, Illness, Drug dose omission by device, Device breakage, |
||||
ALBUTEROL SULFATE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, METHYLPREDNISOLONE, |
||||
| 660 | 25057628 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 661 | 25057844 |
US |
53 | 2 |
Accidental exposure to product, Injury associated with device, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 662 | 25058469 |
US |
84 | 1 |
Agitation, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 663 | 25058717 |
US |
68 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, |
||||
| 664 | 25059046 |
US |
9 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, METHYLPHENIDATE HYDROCHLORIDE, |
||||
| 665 | 25059055 |
GR |
10 | 2 |
Drug dose omission by device, Incorrect dose administered by device, Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 666 | 25059153 |
US |
16 | 1 |
Drug dose omission by device, Device power source issue, |
||||
SOMATROPIN, |
||||
| 667 | 25059160 |
US |
15 | 1 |
Device difficult to use, Device failure, Product reconstitution quality issue, Liquid product physical issue, Device leakage, Drug dose omission by device, Accidental exposure to product, Exposure via skin contact, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 668 | 25059164 |
US |
12 | 2 |
Device breakage, Poor quality device used, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 669 | 25059190 |
US |
10 | 2 |
Drug dose omission by device, Device use issue, Device mechanical issue, Device breakage, Device material issue, Device leakage, Product prescribing error, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 670 | 25059248 |
US |
12 | 1 |
Drug dose omission by device, Device breakage, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 671 | 25059250 |
GR |
14 | 1 |
Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, ANASTROZOLE, |
||||
| 672 | 25059525 |
US |
72 | 1 |
Therapeutic response shortened, Device difficult to use, Wrong technique in product usage process, Accidental exposure to product, Drug dose omission by device, Device use error, |
||||
ERENUMAB-AOOE, |
||||
| 673 | 25059845 |
US |
76 | 2 |
Syncope, Spinal fracture, Fall, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 674 | 25059998 |
US |
17 | 1 |
Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 675 | 25060269 |
US |
||
Drug dose omission by device, Device mechanical issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 676 | 25060446 |
US |
54 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 677 | 25060581 |
US |
70 | 2 |
Product communication issue, Device difficult to use, Drug dose omission by device, Nasopharyngitis, Cough, |
||||
EVOLOCUMAB, TIRZEPATIDE, |
||||
| 678 | 25060638 |
US |
69 | 2 |
Injection site pain, Device difficult to use, Drug dose omission by device, Accidental exposure to product, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 679 | 25061065 |
EG |
10 | 1 |
Therapy cessation, Incorrect dose administered by device, Drug dose omission by device, Wrong technique in product usage process, Product odour abnormal, Poor quality device used, Product availability issue, Device issue, Product substitution, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 680 | 25061222 |
US |
21 | 2 |
Drug dose omission by device, Incorrect dose administered, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 681 | 25055808 |
US |
72 | 2 |
Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 682 | 25055837 |
US |
75 | 2 |
Injection site discolouration, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, |
||||
| 683 | 25055980 |
US |
70 | 2 |
Device difficult to use, Accidental exposure to product, Wrong technique in product usage process, Drug dose omission by device, Injection site haemorrhage, |
||||
EVOLOCUMAB, |
||||
| 684 | 25054588 |
US |
84 | 2 |
Hypoacusis, Wrong technique in product usage process, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 685 | 25054623 |
US |
73 | 1 |
Diabetes mellitus inadequate control, Drug dose omission by device, Device operational issue, |
||||
INSULIN GLARGINE, |
||||
| 686 | 25054673 |
US |
2 | |
Pancreatic carcinoma, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 687 | 25054691 |
US |
||
Syringe issue, Device breakage, Drug dose omission by device, |
||||
ADALIMUMAB, |
||||
| 688 | 25054807 |
US |
69 | 2 |
Increased tendency to bruise, Device difficult to use, Drug dose omission by device, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 689 | 25055376 |
US |
||
Injection site haemorrhage, Injection site injury, Injection site pain, Product use issue, Device delivery system issue, Incorrect dose administered by device, Drug dose omission by device, |
||||
EXENATIDE, |
||||
| 690 | 25055432 |
US |
85 | 2 |
Drug dose omission by device, Device difficult to use, Injection site erythema, |
||||
EVOLOCUMAB, |
||||
| 691 | 25055513 |
US |
2 | |
Unintentional medical device removal, Device adhesion issue, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 692 | 25048222 |
US |
||
Accidental exposure to product, Device leakage, Drug dose omission by device, Exposure via skin contact, |
||||
GUSELKUMAB, |
||||
| 693 | 25048224 |
US |
77 | 1 |
Device difficult to use, Drug dose omission by device, Injection site bruising, Injection site pain, Off label use, |
||||
EVOLOCUMAB, |
||||
| 694 | 25048371 |
US |
1 | |
Accidental exposure to product, Device malfunction, Device issue, Drug dose omission by device, |
||||
SECUKINUMAB, AMLODIPINE, TIRZEPATIDE, |
||||
| 695 | 25048389 |
US |
83 | 1 |
Injury associated with device, Accidental exposure to product, Incorrect dose administered by device, Device difficult to use, Device use error, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 696 | 25048404 |
US |
2 | |
Drug dose omission by device, Device issue, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, |
||||
| 697 | 25048520 |
US |
77 | 2 |
Depression, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 698 | 25048804 |
US |
63 | 2 |
Drug dose omission by device, Needle issue, |
||||
PEGFILGRASTIM-BMEZ, |
||||
| 699 | 25048822 |
US |
76 | 1 |
Condition aggravated, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 700 | 25049014 |
US |
||
Dyspnoea, Illness, Device delivery system issue, Drug dose omission by device, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
disclaimer
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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last_updated
2025-04-28