OMNIPOD INSULIN PUMP Adverse Event — Malfunction (MDR 3004464228-2020-06051)
OMNIPOD INSULIN PUMP Adverse Event — Malfunction (MDR 3004464228-2020-06051) 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 | 3004464228-2020-06051 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE PATIENT REPORTED THE CANNULA WAS NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: UST400. 17845-5A-AW REV B 09/17. CHANGING YOUR POD. C |
| Source | openFDA MAUDE (device adverse events) |
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