FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722NAB PRDGM INS V2.2 BL EN
MDR report key: 1214043
·
Received October 23, 2008
Report
- Report Number
- 3004209178-2008-00886
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- October 10, 2008
- Report Date
- October 10, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 ENCODER SIGNAL BEING OUT OF PHASE. HOWEVER, THE INSULIN PUMP PASSED THE BASIC OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TESTS.
Description of Event or Problem · 1
THE CUSTOMER COMPLAINED OF THE INSULIN PUMP ALARMING MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAB PRDGM INS V2.2 BL EN | INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR |