Device brand name · Insulin delivery device
Novopen 4: medical device reports filed with FDA
567 reports name it, 2009–2026. Manufacturer given most often on reports: Novo Nordisk A/S Medical Systems. Product code FMF.
- 567
- device reports naming the brand
- 0% of all MAUDE reports · about 34 a year
- 67
- reports, 12 months to August 2026
- 90 in the 12 months before
- 3.2%
- classified as malfunction
- 88.5% across the product code
- 0.7%
- classified as death, as reported
- 4 reports · not verified by FDA
FDA's MAUDE database holds 567 reports that name the brand "Novopen 4" (insulin delivery device), received between August 2009 and May 2026; the manufacturer given most often on reports is Novo Nordisk A/S Medical Systems. Spellings of one product vary from report to report.
67 reports arrived in the 12 months to August 2026, down 26% from 90 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (94.4%), malfunction (3.2%) and other (1.4%); across all syringe, piston reports (product code FMF) death is recorded in 0.1% and malfunction in 88.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to deliver (26.6%), inaccurate delivery (26.5%) and defective component (15%). The patient problems coded most often are hyperglycemia, hypoglycemia and elevated ketones/ diabetic ketoacidosis. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 53,081 reports carrying product code FMF. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Failure to deliverthe device did not deliver the dose or item | 151 | 26.6% | 3.6% |
| Inaccurate delivery | 150 | 26.5% | 0.9% |
| Defective component | 85 | 15% | 2.2% |
| Improper or incorrect procedure or method | 76 | 13.4% | 0.6% |
| Mechanical jam | 72 | 12.7% | 0.8% |
| Defective devicethe device was defective | 67 | 11.8% | 1.7% |
| Breakthe device broke | 52 | 9.2% | 9.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 40 | 7.1% | 1% |
| Device handling problem | 27 | 4.8% | 0.1% |
| Infusion or flow problema problem with flow or infusion | 23 | 4.1% | 0.5% |
| No flow | 15 | 2.6% | 0.2% |
| Leak/splashthe device leaked | 14 | 2.5% | 18% |
| Mechanical problema mechanical problem | 14 | 2.5% | 0.6% |
| Device difficult to setup or prepare | 11 | 1.9% | 0.1% |
| Detachment of device or device componentpart of the device came off | 10 | 1.8% | 1.2% |
| Excess flow or over-infusion | 8 | 1.4% | 0.3% |
| Labelling, instructions for use or training problem | 8 | 1.4% | 0.1% |
| Pressure problem | 8 | 1.4% | 0% |
| Failure to fire | 7 | 1.2% | 0% |
| Connection problema connection problem | 6 | 1.1% | 1.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Hyperglycemiahigh blood sugar | 398 | 70.2% |
| Hypoglycemialow blood sugar | 110 | 19.4% |
| Elevated ketones/ diabetic ketoacidosis | 65 | 11.5% |
| Coma | 60 | 10.6% |
| Loss of consciousnesspassing out | 12 | 2.1% |
| Administration site reaction | 8 | 1.4% |
| Dizzinesslight-headedness or unsteadiness | 7 | 1.2% |
| Injurya physical injury | 7 | 1.2% |
| Overdosea dose above the recommended amount | 7 | 1.2% |
| Speech disordera speech problem | 6 | 1.1% |
| Falla fall | 5 | 0.9% |
| Fatiguetiredness | 5 | 0.9% |
| Abnormal blood gases | 4 | 0.7% |
| Stroke/cva | 4 | 0.7% |
| Urinary tract infectionbladder or urinary infection | 4 | 0.7% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Novopen 4 | Product code FMF | All MAUDE reports |
|---|---|---|---|
| Reports | 567 | 53,081 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 7 | 1 | 9 |
| Classified as injury | 94.4% | 9.9% | 36.2% |
| Classified as malfunction | 3.2% | 88.5% | 62.3% |
| Filed by the manufacturer | 100% | 93.7% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code FMF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Inpen Mmt-105nnblna Novo Nordisk Blue | 1,620 | 188 | 0.1% |
| Inpen Mmt-105elblna Eli Lily Blue | 1,292 | 168 | 0.1% |
| Inpen Mmt-105nnpkna Novo Nordisk Pink | 1,142 | 219 | 0.1% |
| Rsvr Mmt-326a 10pk Prdgm 1 8ml 13l | 1,103 | 0 | 0.4% |
| Kit MMT-105NNBLW1 NovoNordisk Blue OUS1 | 1,011 | 655 | 0% |
| BD Luer-Lok | 1,001 | 333 | 0% |
| Inpen Mmt-105nngyna Novo Nordisk Gray | 972 | 143 | 0% |
| Unspecified Bd Syringe | 926 | 0 | 0.1% |
| Bd Insulin Syringe With The Bd Ultra-Fine Needle | 869 | 0 | 0% |
| Bd Ultra-Fine Insulin Syringe | 849 | 0 | 0% |
| Inpen Mmt-105elpkna Eli Lily Pink | 805 | 123 | 0% |
| Inpen Mmt-105elgyna Eli Lily Gray | 736 | 88 | 0% |
| Bd Luer-Lok Tip Syringe | 624 | 0 | 0% |
| Bd Luer-Lok Syringe | 595 | 0 | 0% |
| Rsvr Mmt-332a 10pk Prdgm 3cc 14l | 540 | 0 | 0.7% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Novopen 4 reports
How many FDA reports name Novopen 4?
567 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 67 in the latest 12 months.
What kinds of events are reported?
injury (94.4%), malfunction (3.2%) and other (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to deliver (26.6%), inaccurate delivery (26.5%), defective component (15%), improper or incorrect procedure or method (13.4%) and mechanical jam (12.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Novopen 4 was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.