OMNIPOD INSULIN PUMP Adverse Event — Injury (MDR 3004464228-2020-05977)
OMNIPOD INSULIN PUMP Adverse Event — Injury (MDR 3004464228-2020-05977) 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 | 3004464228-2020-05977 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | CONSUMER |
| Narrative | THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED HOSPITALIZATION AND 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. CHECKING YOUR BLOOD GLUCOSE. CHAPTER 4 / PAGE 36. WARNINGS: |
| Source | openFDA MAUDE (device adverse events) |
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