FDA Adverse Event
Malfunction
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 2222044
·
Received August 17, 2011
Report
- Report Number
- 3004209178-2011-82587
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 24, 2011
- Report Date
- July 24, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- K040676
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY AS A RESULT OF CORRODED INTERFACE BOARD AND MOTHERBOARD. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE FROZEN DISPLAY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD AN ERROR ALARM. THE CUSTOMER COULD NOT CLEAR THE ALARM, AND THE BUTTONS WERE UNRESPONSIVE. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | LZG | MEDTRONIC PUERTO RICO OPERATIONS MED-REL | MMT-515PNAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR |