OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Adverse Event — Injury (MDR 3004464228-2020-06061)
OMNIPOD DASH¿ INSULIN MANAGEMENT SYSTEM Adverse Event — Injury (MDR 3004464228-2020-06061) 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 | 3004464228-2020-06061 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| 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 [ER VISIT/HOSPITALIZATION] AND DIABETIC KETOACIDOSIS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. OMNIPOD DASH INSULIN MANAGEMENT SYSTEM ¿ USER GUIDE. MODEL: 18320. 18296-ENG-AW REV B 06/18. BLOOD GLUCOSE READINGS. CHAPTER 4 / |
| Source | openFDA MAUDE (device adverse events) |
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