FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 1991594
·
Received January 28, 2011
Report
- Report Number
- 2032227-2011-00292
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- September 15, 2010
- Report Date
- January 26, 2010
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP HAD A FROZEN DISPLAY DUE TO CORROSION ON THE LIQUID CRYSTAL DISPLAY BOARD. NO DAMAGE WAS FOUND ON THE KEYPAD TRACE. UNABLE TO PERFORM THE OPERATING CURRENTS DUE TO THE FROZEN DISPLAY.
Description of Event or Problem · 1
THE CUSTOMER CALLED TO REPORT UNRESPONSIVE BUTTONS FOR OVER AN HOUR. THE INSULIN PUMP WAS NOT DROPPED OR BUMPED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PARADIGM REAL-TIME INSULIN INFUSION PUMP | INSULIN INFUSION PUMP | MDS | MEDTRONIC MINIMED | MMT-722LNAP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |