FDA Adverse Event
Malfunction
Summary report: N
BELT CLIP
MDR report key: 4171404
·
Received October 14, 2014
Report
- Report Number
- 2032227-2014-37568
- Event Type
- Malfunction
- Date Received
- October 14, 2014
- Date of Event
- July 14, 2014
- Report Date
- September 14, 2014
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- OYC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PATIENT
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
CUSTOMER REPORTED THAT THE INSULIN PUMP'S DISPLAY WAS BLANK. CUSTOMER REPORTED THAT THE BLANK DISPLAY OCCURRED AFTER A BATTERY CHANGE. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD RETURNED A FAILED BATTERY TEST. BLOOD GLUCOSE LEVEL WAS 127 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650509 | BELT CLIP | INSULIN INFUSION PUMP / SENSOR AUGMENTED | OYC | MEDTRONIC MINIMED | MMT-640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |