FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-512LWWL PRDGM INS CL EN LN
MDR report key: 1160606
·
Received September 5, 2008
Report
- Report Number
- 2032227-2008-01519
- Event Type
- Malfunction
- Date Received
- September 5, 2008
- Date of Event
- August 28, 2008
- Report Date
- August 29, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K030531
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP WAS PRIMING ABNORMALLY AND THAT AN ALARM HAD OCCURRED. 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-512LWWL PRDGM INS CL EN LN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-512LWWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |