OMNIPOD INSULIN MANAGEMENT SYSTEM Adverse Event — Malfunction (MDR 3004464228-2020-06060)
OMNIPOD INSULIN MANAGEMENT SYSTEM Adverse Event — Malfunction (MDR 3004464228-2020-06060) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OMNIPOD INSULIN MANAGEMENT SYSTEM; Generic name: PUMP, INFUSION, INSULIN; Manufacturer: INSULET CORPORATION.
| Device | OMNIPOD INSULIN MANAGEMENT SYSTEM |
|---|---|
| Generic name | PUMP, INFUSION, INSULIN |
| Manufacturer | INSULET CORPORATION |
| Report number | 3004464228-2020-06060 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE CANNULA HAD DISLODGED FROM THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. LOT RELEASE RECORDS WERE REVIEWED AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. OMNIPOD INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE: MODEL: UST400. 17845-5A-AW REV B 09/17. CHANGING YOUR POD: CHAPTER 3 / PAGE 34. WARNINGS: CHEC |
| Source | openFDA MAUDE (device adverse events) |
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