OMNIPOD INSULIN PUMP Adverse Event — Malfunction (MDR 3004464228-2020-05989)
OMNIPOD INSULIN PUMP Adverse Event — Malfunction (MDR 3004464228-2020-05989) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OMNIPOD INSULIN PUMP; Generic name: PUMP, INFUSION, INSULIN; Manufacturer: INSULET CORPORATION.
| Device | OMNIPOD INSULIN PUMP |
|---|---|
| Generic name | PUMP, INFUSION, INSULIN |
| Manufacturer | INSULET CORPORATION |
| Report number | 3004464228-2020-05989 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER, FOREIGN |
| Narrative | THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO CONFIRM THE REPORTED BENT CANNULA OR TO DETERMINE WHETHER IT CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: CAT45E/CAT45F, 15546-AW REV D 06/2016. CHECKING YOUR BLOOD GLUCOSE 7 / PAGE 98: WARNING: IF YOU |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →