FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722NAP PRDGM INS V2.2 PL EN
MDR report key: 1843612
·
Received September 20, 2010
Report
- Report Number
- 2032227-2010-82683
- Event Type
- Malfunction
- Date Received
- September 20, 2010
- Date of Event
- August 29, 2010
- Report Date
- August 29, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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. 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 NO DELIVERY ALARMS DURING THE MANUAL PRIME. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT 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-722NAP PRDGM INS V2.2 PL EN | INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722NAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |