Device brand name · Pen injector for treatment purposes
Humapen Memoir: medical device reports filed with FDA
253 reports name it, 2008–2018. Manufacturer given most often on reports: Eli Lilly And. Product code NSC.
- 253
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 87.4%
- classified as malfunction
- 71.1% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 253 reports that name the brand "Humapen Memoir" (pen injector for treatment purposes), received between March 2008 and October 2018; the manufacturer given most often on reports is Eli Lilly And. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none 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 malfunction (87.4%) and injury (12.6%); across all injector, pen reports (product code NSC) death is recorded in 0.1% and malfunction in 71.1%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are no display/image (28.9%), image display error/artifact (13%) and poor quality image (11.1%). The patient problems coded most often are hyperglycemia, hospitalization required and hypoglycemia. 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
No report naming Humapen Memoir was received in the five years to August 2026; the latest was received in October 2018.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 671 reports carrying product code NSC. 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 |
|---|---|---|---|
| No display/image | 73 | 28.9% | 9.2% |
| Image display error/artifact | 33 | 13% | 5.1% |
| Poor quality image | 28 | 11.1% | 4.2% |
| Display or visual feedback problem | 21 | 8.3% | 2.7% |
| Optical distortion | 20 | 7.9% | 3% |
| Component missing | 19 | 7.5% | 5.2% |
| Battery problema problem with the battery | 10 | 4% | 1.9% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 4% | 5.7% |
| Device displays incorrect message | 9 | 3.6% | 1.5% |
| Defective devicethe device was defective | 8 | 3.2% | 3.6% |
| Erratic or intermittent display | 8 | 3.2% | 1% |
| Improper or incorrect procedure or method | 7 | 2.8% | 4.5% |
| Device inoperablethe device could not be used | 5 | 2% | 1.8% |
| Breakthe device broke | 4 | 1.6% | 15.8% |
| Failure to reset | 4 | 1.6% | 0.7% |
| Crackthe device cracked | 3 | 1.2% | 1.3% |
| Device markings/labelling problema problem with the device markings or label | 3 | 1.2% | 1.2% |
| Display difficult to read | 3 | 1.2% | 0.4% |
| Defective component | 2 | 0.8% | 1% |
| Inadequate or insufficient training | 2 | 0.8% | 0.3% |
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 | 11 | 4.3% |
| Hospitalization required | 6 | 2.4% |
| Hypoglycemialow blood sugar | 6 | 2.4% |
| Blood glucose, high | 5 | 2% |
| Elevated ketones/ diabetic ketoacidosis | 4 | 1.6% |
| Treatment with medication(s) | 4 | 1.6% |
| Loss of consciousnesspassing out | 3 | 1.2% |
| Blood glucose, low | 2 | 0.8% |
| No patient involvement | 2 | 0.8% |
| Ambulation or postural difficulties | 1 | 0.4% |
| Anxietyanxiety | 1 | 0.4% |
| Arthralgiajoint pain | 1 | 0.4% |
| Blurred vision | 1 | 0.4% |
| Burning sensationa burning feeling | 1 | 0.4% |
| Coma | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Humapen Memoir | Product code NSC | All MAUDE reports |
|---|---|---|---|
| Reports | 253 | 671 | 26,136,888 |
| Share of that pool | — | 37.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 12.6% | 27.3% | 36.2% |
| Classified as malfunction | 87.4% | 71.1% | 62.3% |
| Filed by the manufacturer | 100% | 85.5% | 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 NSC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Humapen Ergo Teal/Clear | 173 | 0 | 0% |
| HumaPen Luxura Half-Dose Pen | 190 | 11 | 0% |
| Unspecified Bd Pen Needle | 1,820 | 0 | 0.1% |
| Bd Autoshield Duo Safety Pen Needle | 208 | 0 | 0% |
| Bd Ultra-Fine Pen Needle | 320 | 0 | 0% |
| Pen Ndl 32g 4mm Hp 100 Box 1200 Us | 222 | 0 | 0% |
| Pen Ndl 32g 4mm Pro 14 Bag 700 Case Jpx | 235 | 19 | 0% |
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 Humapen Memoir reports
How many FDA reports name Humapen Memoir?
253 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (87.4%) and injury (12.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
no display/image (28.9%), image display error/artifact (13%), poor quality image (11.1%), display or visual feedback problem (8.3%) and optical distortion (7.9%). 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 Humapen Memoir 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.