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Drug:

Reaction: DEVICE MALFUNCTION

20260101 - 20261231

No. 1 - 100

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No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
1
26940099
US
 69 1
Drug dose omission by device, Device malfunction,
PEGFILGRASTIM,
2
26940254
US
 69
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
3
26940676
US
 66 2
Condition aggravated, Diarrhoea, Nausea, Drug dose omission by device, Device malfunction, Device mechanical issue, Device physical property issue,
ABALOPARATIDE,
4
26940692
EU
 50 2
Asphyxia, Circumstance or information capable of leading to medication error, Device malfunction,
5
26940751
US
 2
Incorrect dose administered by device, Device failure, Device malfunction, Device mechanical issue, No adverse event,
LIRAGLUTIDE,
6
26941573
US
 43
Dermatitis atopic, Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO,
7
26941719
US
 79
Injection site haemorrhage, Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
8
26941745
US
No adverse event, Device malfunction, No adverse event, Device malfunction,
PEGFILGRASTIM-CBQV,
9
26941821
US
 82
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
10
26941947
BR
 70 2
Asphyxia, Renal failure, Product use issue, Dengue fever, Osteoporosis, Device malfunction, Off label use,
BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, CALCIUM, AMLODIPINE BESYLATE,
11
26942190
US
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO,
12
26942212
US
 62 2
Hip fracture, Multiple sclerosis, Device malfunction, Fall, Gait disturbance,
OFATUMUMAB, OFATUMUMAB,
13
26942594
US
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO,
14
26943174
US
 34
Incorrect dose administered, Device malfunction,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
15
26943321
US
 1
Device malfunction, Drug dose omission by device, Feeling abnormal,
ORAL SEMAGLUTIDE,
16
26943833
US
 35
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
17
26943984
US
 5 1
Incorrect dose administered, Wrong technique in device usage process, Device malfunction,
LONAPEGSOMATROPIN-TCGD,
18
26944574
US
 1
Injection site swelling, Accidental exposure to product, Exposure via skin contact, Device malfunction,
DUPILUMAB,
19
26945144
US
 75 2
Device loosening, Device malfunction, Product dose omission issue, Wrong technique in product usage process,
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE,
20
26945196
US
 64
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
21
26945292
US
 67
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
22
26945536
US
 2
Drug dose omission by device, Product use in unapproved indication, Device malfunction, Device delivery system issue,
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, SPIRONOLACTONE, DESVENLAFAXINE SUCCINATE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, THYROID, PORCINE,
23
26945780
US
 69 2
Therapeutic response unexpected, Device malfunction,
ABALOPARATIDE,
24
26945949
US
 70 2
Device defective, Drug dose omission by device, Device malfunction, Needle issue,
ABALOPARATIDE, ABALOPARATIDE, ORAL SEMAGLUTIDE,
25
26945956
US
 69 2
Device malfunction, Therapeutic response unexpected,
ABALOPARATIDE,
26
26945976
US
 77 2
Chills, Tremor, Device malfunction, Incorrect product administration duration, Product dose omission issue,
ABALOPARATIDE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, CALCIUM, FISH OIL, LISINOPRIL, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, SERTRALINE HYDROCHLORIDE,
27
26946139
US
 2
Weight increased, Hyperhidrosis, Sleep disorder, Paraesthesia, Formication, Oedema peripheral, Joint swelling, Injection site urticaria, Night sweats, Nausea, Dizziness, Headache, Bone pain, Fatigue, Arthralgia, Abdominal pain upper, Abdominal distension, Device malfunction,
ABALOPARATIDE, ROSUVASTATIN,
28
26946369
US
 84 2
Injection site pain, Injection site reaction, Fatigue, Device malfunction, Drug dose omission by device, Product dose omission in error,
ABALOPARATIDE, ABALOPARATIDE,
29
26946627
US
 84 1
Drug dose omission by device, Product supply issue, Device malfunction,
ABALOPARATIDE, ABALOPARATIDE,
30
26946764
US
 44 1
Product dose omission issue, Device issue, Device malfunction,
ABALOPARATIDE, ABALOPARATIDE,
31
26947106
US
 45 2
Device malfunction, Device leakage, Drug dose omission by device,
32
26947193
US
 73 2
Product dose omission issue, Device defective, Device malfunction,
ABALOPARATIDE,
33
26947197
US
 75 2
Depressed mood, Muscular weakness, Musculoskeletal discomfort, Blood urea increased, Nausea, Back pain, Blood calcium increased, Device malfunction,
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, FENOFIBRATE, IRON, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, EVOLOCUMAB, ACYCLOVIR, AMOXICILLIN, FAMOTIDINE, EPINEPHRINE, ALPRAZOLAM, SERTRALINE HYDROCHLORIDE, CEPHALEXIN, CETIRIZINE HYDROCHLORIDE, ALBUTEROL SULFATE, IPRATROPIUM BROMIDE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, CYCLOSPORINE,
34
26947311
US
 66 2
Product dose omission in error, Device malfunction, Device issue,
ABALOPARATIDE, ABALOPARATIDE,
35
26947489
US
 2
Urticaria, Allergy to plants, Device malfunction, Drug dose omission by device, Device difficult to use,
ABALOPARATIDE,
36
26947692
US
 30
Device malfunction, Incorrect dose administered,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
37
26947822
US
 59 2
Skin irritation, Herpes zoster, Device malfunction, Product use issue, Drug dose omission by device, Product administered at inappropriate site,
ABALOPARATIDE, ABALOPARATIDE,
38
26948009
US
 71
Pruritus, Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO,
39
26934421
US
 63 2
Product dose omission issue, Device malfunction, No adverse event,
TOCILIZUMAB, HYDROXYCHLOROQUINE SULFATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, FOLIC ACID, MELOXICAM, ESOMEPRAZOLE MAGNESIUM, MONTELUKAST SODIUM, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE INJECTION, METHOTREXATE, METHOTREXATE SODIUM,
40
26934616
GB
 58
Uveitis, Device malfunction, Product leakage, Accidental exposure to product, Exposure via skin contact, Drug ineffective,
ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY,
41
26934816
US
 35 2
Device malfunction,
PEGFILGRASTIM,
42
26934983
US
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
43
26935214
US
 2
Device use issue, Medication error, Device malfunction, Product cleaning inadequate,
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE,
44
26935420
US
 66 2
Device malfunction,
PEGFILGRASTIM, PEGFILGRASTIM,
45
26935524
BR
 1
Nasopharyngitis, Pneumonia, Immunodeficiency, Off label use, Device malfunction,
BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE,
46
26935530
US
 55
Device malfunction, Incorrect dose administered,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
47
26935702
US
 71
Device malfunction, Product dose omission issue, Intentional product use issue,
NEMOLIZUMAB-ILTO, LISINOPRIL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ZOLPIDEM TARTRATE,
48
26935765
US
Device delivery system issue, Device malfunction,
ALBUTEROL SULFATE AND BUDESONIDE,
49
26935806
US
 60 1
Off label use, Device malfunction, Product dose omission issue, No adverse event,
VEDOLIZUMAB, VEDOLIZUMAB,
50
26936025
US
 1
Injection site pain, Device malfunction,
DUPILUMAB, ALPRAZOLAM, CEFIXIME, FLUTICASONE PROPIONATE, MELOXICAM, MONTELUKAST, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ROSUVASTATIN,
51
26936130
US
 73
Incorrect dose administered, Device malfunction,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
52
26936181
US
 82
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO,
53
26936195
US
 10 2
Product dose omission issue, Device malfunction, Device defective, No adverse event,
OMALIZUMAB, OMALIZUMAB, CETIRIZINE HYDROCHLORIDE,
54
26937814
US
 76 2
Drug delivery system malfunction, Dyspnoea, Product dose omission issue, Device malfunction, Product quality issue,
ALBUTEROL SULFATE,
55
26938421
US
 51 2
Psoriatic arthropathy, Device malfunction, Product dose omission issue, Hidradenitis, Condition aggravated, Product leakage, Inappropriate schedule of product administration,
BIMEKIZUMAB, BIMEKIZUMAB,
56
26938566
US
 64 2
Device malfunction, Ear infection, Injection site discharge, Injection site swelling,
VEDOLIZUMAB, VEDOLIZUMAB,
57
26938719
US
 2 1
Device malfunction,
SOMATROPIN,
58
26938941
US
 2
Product container seal issue, Drug dose omission by device, Product use in unapproved indication, Product administered at inappropriate site, Device malfunction,
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), DUPILUMAB, AMLODIPINE BESYLATE,
59
26938952
US
 72 2
Injection site bruising, Product dose omission issue, Therapeutic product effect incomplete, Therapy interrupted, Product use complaint, Device malfunction, Product use issue, Device defective,
ABALOPARATIDE,
60
26939131
US
 52 2
Device malfunction,
PEGFILGRASTIM, PEGFILGRASTIM,
61
26939265
US
 2
Dermal cyst, Balance disorder, Musculoskeletal stiffness, Nausea, Injection site erythema, Contusion, Drug dose omission by device, Device malfunction, Needle issue,
ABALOPARATIDE, ABALOPARATIDE, ERGOCALCIFEROL, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, AMLODIPINE, BIOTIN, BUPROPION HYDROCHLORIDE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, FOLIC ACID, HYDROXYCHLOROQUINE, METHOTREXATE, METHOTREXATE SODIUM,
62
26939501
US
 2
Adverse event, Dizziness, Product supply issue, Product dose omission issue, Device malfunction, Device issue,
ABALOPARATIDE, ABALOPARATIDE,
63
26939663
US
 79 2
Dizziness, Palpitations, Heart rate increased, Device mechanical issue, Device malfunction, Product dose omission issue, Product administered at inappropriate site,
ABALOPARATIDE,
64
26939814
US
 2
Fat redistribution, Injection site mass, Device malfunction, Product use issue,
ABALOPARATIDE, ABALOPARATIDE, VALACYCLOVIR HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE,
65
26931540
US
 26
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO,
66
26932110
US
 60
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
67
26932178
US
 70
Intentional product use issue, Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
68
26932179
EU
Syncope, Incorrect dose administered by device, Device malfunction,
69
26932239
US
No adverse event, Device malfunction, Device malfunction, No adverse event,
PEGFILGRASTIM-CBQV,
70
26932267
US
Device malfunction, No adverse event, Device failure, No adverse event, Device failure, Device malfunction,
PEGFILGRASTIM-CBQV,
71
26932339
US
Device malfunction, Device malfunction, No adverse event,
PEGFILGRASTIM-CBQV,
72
26932347
US
 1
No adverse event, Device malfunction, No adverse event, Device malfunction,
PEGFILGRASTIM-CBQV,
73
26933082
US
 33
Device malfunction, Incorrect dose administered,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
74
26933084
US
 81
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO,
75
26933098
US
 61
Device malfunction, Product dose omission issue,
NEMOLIZUMAB-ILTO,
76
26933180
US
 2
Drug dose omission by device, Device malfunction, Device leakage, Device leakage, Product quality issue,
77
26933279
US
 68
Product dose omission issue, Device malfunction,
NEMOLIZUMAB-ILTO,
78
26927049
US
 2
Device malfunction, Brain fog, Dyspnoea, Pain in extremity, Anxiety, Dyspepsia, Blood pressure increased, Diarrhoea, Nausea, Dehydration, Feeling hot, Dry mouth, Oedema, Fatigue, Therapy non-responder,
TREPROSTINIL, TREPROSTINIL, ESTRADIOL, FOLLICULINUM, OOPHORINUM (SUIS), PROGESTERONE, FUROSEMIDE, FAMOTIDINE, SPIRONOLACTONE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE, MAGNESIUM OXIDE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, MACITENTAN, SELENIUM, PSYLLIUM HUSK, ARNICA MONTANA FLOWER, ERGOCALCIFEROL, VALERIAN, MOMETASONE FUROATE, MOMETASONE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, SOTATERCEPT-CSRK, TADALAFIL, EPOPROSTENOL, SACCHAROMYCES CEREVISIAE, TIZANIDINE HYDROCHLORIDE, OXYGEN, 0XYGEN, CALCIUM CARBONATE, ANTACID, LEVONORGESTREL,
79
26927303
US
 2
Device malfunction, Accidental exposure to product, Product dose omission issue, Injection site bruising, Injection site haemorrhage, Off label use,
GOLIMUMAB, GOLIMUMAB,
80
26927415
US
 75
Drug dose omission by device, Device malfunction, Wrong technique in product usage process performed in error, Device deposit issue, No adverse event,
ALBUTEROL SULFATE,
81
26927596
US
 25 2
Device defective, Device malfunction, Device leakage, Injection site erythema, Drug dose omission by device,
82
26927700
US
 36 1
Colitis ulcerative, Device malfunction, Incorrect dose administered,
VEDOLIZUMAB, VEDOLIZUMAB, URSODIOL, URSOSIOL,
83
26928306
US
 2
Accidental exposure to product, Blood glucose increased, Device leakage, Device malfunction, Drug dose omission by device,
INSULIN ASPART,
84
26928333
US
Device malfunction,
GUSELKUMAB,
85
26928492
US
 7 2
Device malfunction, Lack of injection site rotation,
LONAPEGSOMATROPIN-TCGD,
86
26928569
US
 14 2
Pneumonia, Gait disturbance, Delusion, Product dose omission issue, Device malfunction, Device issue, Product temperature excursion issue, Product availability issue,
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO,
87
26928864
US
No adverse event, Device malfunction, No adverse event, Device malfunction,
PEGFILGRASTIM-CBQV,
88
26928961
US
 70 2
Product dose omission issue, Neutrophil count decreased, Device malfunction, Neutrophil count decreased, Product dose omission issue, Device malfunction,
PEGFILGRASTIM-CBQV, CETUXIMAB, PACLITAXEL, PACLITAXEL (AIBUMIN-BOUND), CARBOPLATIN,
89
26928979
US
No adverse event, Device malfunction, No adverse event, Device malfunction,
PEGFILGRASTIM-CBQV,
90
26929109
US
 86 2
Wrong technique in product usage process, Device delivery system issue, Device malfunction, Device loosening,
BUDESONIDE AND FORMOTEROL FUMARATE,
91
26929268
US
 83 2
Wrong technique in device usage process, Product prescribing issue, Device malfunction,
BUDESONIDE AND FORMOTEROL FUMARATE,
92
26929998
US
 62 2
Psoriatic arthropathy, Device malfunction, Product dose omission issue, Therapeutic response unexpected,
BIMEKIZUMAB, BIMEKIZUMAB,
93
26930280
US
 43 2
Product dose omission issue, Wrong technique in device usage process, Product delivery mechanism issue, Device malfunction, Product cleaning inadequate,
ALBUTEROL SULFATE AND BUDESONIDE,
94
26930696
US
 2
Asthma, Cough, Device malfunction, Vision blurred, Device use error, Product delivery mechanism issue,
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE,
95
26930754
US
Device malfunction, No adverse event, Device malfunction,
PEGFILGRASTIM-CBQV,
96
26930968
US
 12 1
Device malfunction, Drug dose omission by device,
SOMATROPIN,
97
26921549
US
Visual impairment, Drug ineffective, Blood glucose increased, Device malfunction,
INSULIN ASPART,
98
26921610
US
 37 2
Injection site injury, Product storage error, Skin pressure mark, Device malfunction, Incorrect dose administered by device,
99
26922497
US
 1
Device malfunction,
NITRIC OXIDE, NITRIC OXIDE,
100
26922499
US
Device malfunction,
NITRIC OXIDE, NITRIC OXIDE,

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last_updated

2026-07-30

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