FDA Adverse Event
Injury
Summary report: N
MINIMED 670G INSULIN PUMP
MDR report key: 10307491
·
Received July 21, 2020
Report
- Report Number
- MW5095645
- Event Type
- Injury
- Date Received
- July 21, 2020
- Date of Event
- July 17, 2020
- Report Date
- July 17, 2020
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OZP
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- LA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I USE A MEDTRONIC 670G INSULIN PUMP. I RECEIVED MULTIPLE ERRORS, ERROR NO 37, "DELIVERY STOPPED. SETTINGS UNCHANGED. PUMP RESTART NEEDED, SELECT OK TO RESTART. I WAS ADVISED, MY A MEDTRONIC REPRESENTATIVE THAT THE ERROR COULD NOT BE CORRECTED AND A NEW PUMP WOULD BE ISSUED BUT COULD NOT BE DELIVERED OVERNIGHT. ESTIMATED DELIVERY DATE IS (B)(6) 2020. FDA SAFETY REPORT ID # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 766780 | MINIMED 670G INSULIN PUMP | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | OZP | MEDTRONIC MINIMED | MMT-1780 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |