FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722NAL PRDGM IN V2.2 CL EN PR
MDR report key: 1843691
·
Received September 21, 2010
Report
- Report Number
- 3004209178-2010-82862
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- August 31, 2010
- Report Date
- August 31, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY. PROBLEM ISOLATED TO THE INTERFACE BOARD.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED AN ERROR ALARM AND HAD A BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WAS RESTED AND THE DISPLAY STILL DID NOT RETURN. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAL PRDGM IN V2.2 CL EN PR | INFUSION PUMP | MDS | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-722NAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR |