FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722LNAS PRDGM INS SK EN ML
MDR report key: 1853661
·
Received September 29, 2010
Report
- Report Number
- 2032227-2010-82822
- Event Type
- Malfunction
- Date Received
- September 29, 2010
- Date of Event
- September 13, 2010
- Report Date
- September 13, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A FROZEN SCREEN. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722LNAS PRDGM INS SK EN ML | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR |