FDA Adverse Event
Malfunction
Summary report: N
NAS PRDGM INSULIN PUMP
MDR report key: 7907372
·
Received September 25, 2018
Report
- Report Number
- 2032227-2018-33166
- Event Type
- Malfunction
- Date Received
- September 25, 2018
- Date of Event
- September 7, 2018
- Report Date
- September 25, 2018
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED VIA PHONE CALL THAT UNEXPECTED RESTART WAS OCCURRED IN INSULIN PUMP. BLOOD GLUCOSE WAS 123 MG/DL. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS RECEIVING SAME ERROR AFTER BATTERY CHANGED. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 745438 | NAS PRDGM INSULIN PUMP | PUMP, INFUSION, INSULIN | OYC | MEDTRONIC MINIMED | MMT-XXX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |