FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722RNAB PRDGM INS BL EN RC
MDR report key: 1172685
·
Received September 19, 2008
Report
- Report Number
- 2032227-2008-01639
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 5, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP FAILED THE DISPLACEMENT TEST AND ALARMED MOTOR ERROR, DUE TO THE MOTOR ENCODED SIGNAL BEING OUT OF PHASE.
Description of Event or Problem · 1
THE CUSTOMER'S HUSBAND COMPLAINED OF THE INSULIN PUMP ALARMING MOTOR ERROR DURING THE MANUAL PRIME. TROUBLESHOOTING WAS PERFORMED, AND THE DISPLACEMENT TEST COULD NOT BE COMPLETED DUE TO THE MOTOR ERROR ALARM OCCURRING DURING REWIND. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN TO TREAT HER DIABETES. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722RNAB PRDGM INS BL EN RC | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-722RNAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |