FDA Adverse Event
Malfunction
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 2212868
·
Received July 12, 2011
Report
- Report Number
- 3004209178-2011-82134
- Event Type
- Malfunction
- Date Received
- July 12, 2011
- Date of Event
- June 20, 2011
- Report Date
- July 7, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- K053177
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSULIN PUMP HAD AN ERROR ALARM. TROUBLESHOOTING WAS PERFORMED. THE ALARM HISTORY REVEALED SEVERAL ERROR ALARMS. A DISPLACEMENT TEST WAS PERFORMED AND THE TEST FAILED. 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-712EWS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |