FDA Adverse Event
Malfunction
Summary report: N
PARADIGM REAL-TIME INSULIN INFUSION PUMP
MDR report key: 2060766
·
Received April 8, 2011
Report
- Report Number
- 3004209178-2011-80987
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- March 18, 2011
- Report Date
- April 1, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- MDS
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AFTER THE BATTERY WAS INSTALLED AND THE INSULIN PUMP POWERED UP, THE INSULIN PUMP STOPPED AND FROZE, FOLLOWED BY AN UNEXPECTED CONSTANT TONE/ALARM. THE PROBLEM HAS BEEN ISOLATED TO THE MOTHERBOARD. ALSO, THE INSULIN PUMP WAS RECEIVED WITH MOISTURE DAMAGE AT THE LCD BOARD. AS A RESULT OF THE FROZEN SCREEN, WE WERE UNABLE TO VERIFY THE UNEXPECTED LOW BATTERY ALARMS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP NEEDED THE BATTERIES REPLACED EVERY THREE DAYS. THE CUSTOMER'S MOTHER STATED THAT THE BATTERY WAS CHANGED TWO DAYS AFTER THE PREVIOUS BATTERY CHANGE. 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 PUERTO RICO OPERATIONS MED-REL | MMT-522NAB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR |