OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Adverse Event — Malfunction (MDR 3004464228-2020-06059)
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Adverse Event — Malfunction (MDR 3004464228-2020-06059) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM; Generic name: PUMP, INFUSION, INSULIN; Manufacturer: INSULET CORPORATION.
| Device | OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM |
|---|---|
| Generic name | PUMP, INFUSION, INSULIN |
| Manufacturer | INSULET CORPORATION |
| Report number | 3004464228-2020-06059 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE USER REPORTED THAT 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 DASH INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: 18320. 18296-ENG-AW REV B 06/18. CHANGING YOUR POD. CHAPTER |
| Source | openFDA MAUDE (device adverse events) |
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