FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-522LWWL PRDGM INS CL EN LN
MDR report key: 1942222
·
Received December 22, 2010
Report
- Report Number
- 2032227-2010-83513
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 13, 2010
- Report Date
- December 17, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- NOT APPLICABLE
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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP HAD UNRESPONSIVE BUTTONS AND A FROZEN DISPLAY. THE BATTERY WAS REPLACED, BUT THE ISSUES CONTINUED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-522LWWL PRDGM INS CL EN LN | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-522LWWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |