MedDRA preferred term · a mistake in using the device

Device use error: adverse event reports recording this term

33,630 reports to FDA record it, 2008–2026; 0.2% 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.

33,630
reports recording the term: 0.2% of all reports; 2,588
reports, 12 months to June 2026: 2,419 in the 12 months before; 7.4%
marked serious by the reporter: 57.4% across all reports; 0.3%
record death among outcomes, as reported: 9.1% across all reports

"Device use error" (in plain words, a mistake in using the device) is a MedDRA preferred term recorded in 33,630 adverse event reports received by FDA, 0.2% of the database, from March 2008 to June 2026. The term is chosen by whoever codes the report to match what the reporter described.

2,588 reports recorded it in the 12 months to June 2026, close to the 2,419 of 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, 7.4% are marked serious, 0.3% include death among the outcomes and 3.4% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Neulasta, Ventolin Hfa and Repatha. 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	6,041	7.5%
Ventolin Hfa	beta2-Adrenergic agonist	4,695	20.7%
Repatha	PCSK9 inhibitor	4,246	2.7%
Tanzeum	—	4,056	48.1%
Genotropin	—	3,084	6.9%
Advair Diskus	Corticosteroid	1,426	6.9%
Aimovig	—	838	1.6%
Enbrel	Tumor necrosis factor blocker	774	0.1%
Breo Ellipta	Corticosteroid	769	3.5%
Remodulin	Prostacycline vasodilator	539	1.1%
Mirena	Progestin	526	0.4%
Albuterol sulfate	beta2-Adrenergic agonist	504	1.1%
Anoro Ellipta	Anticholinergic	429	3.4%
Humira	—	428	0.1%
Trelegy Ellipta	Anticholinergic	396	1.5%
Flovent Diskus	—	391	14.6%
Flovent	Corticosteroid	360	3.3%
Nemluvio	—	315	2.6%
Advair Hfa	Corticosteroid	296	1.5%
Benlysta	B lymphocyte stimulator-specific inhibitor	170	0.7%
Nucala	Interleukin-5 antagonist	166	0.5%
Incruse Ellipta	Anticholinergic	164	3.6%
Omnitrope	Recombinant human growth hormone	153	1.4%
Diazepam	Benzodiazepine	95	0.2%
Cosentyx	Interleukin-17A antagonist	88	0.1%

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 0.2% 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	6,070	5.6%	0.1%
beta2-Adrenergic agonist	5,222	5.7%	0%
PCSK9 inhibitor	4,272	2.4%	0.2%
Corticosteroid	3,126	0.4%	0%
Anticholinergic	1,026	0.6%	0%
Tumor necrosis factor blocker	881	0.1%	0%
Prostacycline vasodilator	669	0.6%	0.1%
Progestin	601	0.2%	0%
Recombinant human growth hormone	228	1.1%	0.5%
Interleukin-5 antagonist	174	0.4%	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%64

2 to 113.9%1,307

12 to 174.4%1,481

18 to 446.5%2,195

45 to 6418.6%6,267

65 to 7413.5%4,528

75 and over9.9%3,332

Age not given43%14,456

Patient sex

Female58.9%19,803

Male34.2%11,495

Not given6.9%2,332

Grey bar: all 20,646,523 reports in the database. 96% of these reports give the United States as the country.

Questions about "Device use error"

What does "Device use error" mean in an adverse event report?

In plain language: a mistake in using the device. 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 use error?

33,630 reports through June 2026 (0.2% of all reports), 2,588 of them in the latest 12 months.

Which drugs appear most often in these reports?

Neulasta (6,041), Ventolin Hfa (4,695), Repatha (4,246), Tanzeum (4,056) and Genotropin (3,084). 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.