FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-715LNAS PRDGM INS V2.1 SK EN
MDR report key: 1874062
·
Received October 15, 2010
Report
- Report Number
- 2032227-2010-82955
- Event Type
- Malfunction
- Date Received
- October 15, 2010
- Date of Event
- September 28, 2010
- Report Date
- September 28, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT SHE DROPPED THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED. THERE WERE NO MISSING SEGMENTS ON THE SCREEN, AND THE SELF TEST PASSED. THE INSULIN PUMP PASSED THE PRIME TEST, BUT FAILED THE HIGH PRESSURE 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-715LNAS PRDGM INS V2.1 SK EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-715LNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |