FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-512LNAS PRDGM INS SK EN US LN
MDR report key: 1000879
·
Received February 21, 2008
Report
- Report Number
- 2032227-2008-00362
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- February 8, 2008
- Report Date
- February 8, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K030531
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP HAD NO AUDIBLE TONE DUE TO A BROKEN TRANSDUCER WIRE. THE INSULIN PUMP ALSO WAS UNABLE TO PRIME DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR. UNABLE TO PERFORM FURTHER TESTING DUE TO THE PRIME ANOMALY.
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE INSULIN PUMP HAD NO AUDIO TONES. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP DID NOT BEEP DURING THE TONE TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-512LNAS PRDGM INS SK EN US LN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-512LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |