FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-522PNAS PRDGM INS SK EN PW
MDR report key: 1843614
·
Received September 20, 2010
Report
- Report Number
- 2032227-2010-82697
- Event Type
- Malfunction
- Date Received
- September 20, 2010
- Date of Event
- August 30, 2010
- Report Date
- August 30, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP ALARMED MOTOR ERROR DURING THE REWIND DUE TO A CORRODED MOTOR HOME SWITCH. UNABLE TO PERFORM THE DISPLACEMENT TEST DUE TO THE MOTOR ERROR ALARMS.
Description of Event or Problem · 1
THE CUSTOMER REPORTED MULTIPLE MOTOR ERROR ALARMS. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. 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-522PNAS PRDGM INS SK EN PW | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-522PNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |