MedDRA preferred term · the device did not work properly

Device malfunction: adverse event reports recording this term

66,314 reports to FDA record it, 2004–2026; 0.3% of the database.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

66,314
reports recording the term: 0.3% of all reports; 8,111
reports, 12 months to June 2026: 5,134 in the 12 months before; 19.8%
marked serious by the reporter: 57.4% across all reports; 0.6%
record death among outcomes, as reported: 9.1% across all reports

"Device malfunction" (in plain words, the device did not work properly) is a MedDRA preferred term recorded in 66,314 adverse event reports received by FDA, 0.3% of the database, from July 2004 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

8,111 reports recorded it in the 12 months to June 2026, up 58% from 5,134 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 19.8% are marked serious, 0.6% include death among the outcomes and 6.7% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Neulasta, Humira and Symbicort. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Neulasta	Leukocyte growth factor	6,764	8.4%
Humira	—	3,445	0.5%
Symbicort	Corticosteroid	2,604	6.7%
Cosentyx	Interleukin-17A antagonist	2,504	1.7%
Simponi	Tumor necrosis factor blocker	2,463	3.5%
Bydureon Bcise	—	2,231	17.3%
Orencia	Selective T cell costimulation modulator	2,085	1.9%
Lantus	Insulin analog	2,082	5.3%
Nemluvio	—	2,066	17%
Solostar	—	2,037	17%
Genotropin	—	1,925	4.3%
Tremfya	Interleukin-23 antagonist	1,626	5.1%
Bydureon	—	1,432	7.3%
Albuterol sulfate	beta2-Adrenergic agonist	1,346	3%
Enbrel	Tumor necrosis factor blocker	1,325	0.2%
Tudorza Pressair	Anticholinergic	1,268	32.9%
Asmanex	Corticosteroid	1,109	23.1%
Risperdal Consta	—	878	6.5%
Udenyca	Leukocyte growth factor	820	66.6%
Wegovy	GLP-1 receptor agonist	818	4.2%
Breztri	Corticosteroid	800	11.1%
Humira 40 Mg/0 8 Ml Pen	—	724	4.7%
Dulera	Corticosteroid	690	9.5%
Remodulin	Prostacycline vasodilator	680	1.4%
Stelara	Interleukin-12 antagonist	631	0.7%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0.3% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Leukocyte growth factor	7,735	7.1%	0.5%
Corticosteroid	7,179	0.9%	0%
Tumor necrosis factor blocker	4,356	0.4%	0%
Insulin analog	3,180	1.1%	0.2%
Interleukin-17A antagonist	2,583	1.4%	0.1%
Selective T cell costimulation modulator	2,482	1.9%	1.9%
beta2-Adrenergic agonist	2,030	2.2%	2.8%
GLP-1 receptor agonist	1,926	0.5%	0.1%
Anticholinergic	1,695	1.1%	0%
Interleukin-23 antagonist	1,670	1.4%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.2%103

2 to 111.6%1,043

12 to 172%1,313

18 to 449.8%6,504

45 to 6419.4%12,867

65 to 7411.5%7,618

75 and over7.2%4,799

Age not given48.4%32,067

Patient sex

Female52.6%34,890

Male27.9%18,534

Not given19.4%12,890

Grey bar: all 20,646,523 reports in the database. 90.6% of these reports give the United States as the country.

Questions about "Device malfunction"

What does "Device malfunction" mean in an adverse event report?

In plain language: the device did not work properly. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record device malfunction?

66,314 reports through June 2026 (0.3% of all reports), 8,111 of them in the latest 12 months.

Which drugs appear most often in these reports?

Neulasta (6,764), Humira (3,445), Symbicort (2,604), Cosentyx (2,504) and Simponi (2,463). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.