FDA Adverse Event
Malfunction
Summary report: N
PARADIGM INSULIN INFUSION PUMP
MDR report key: 2083273
·
Received April 13, 2011
Report
- Report Number
- 3004209178-2011-81018
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- December 2, 2010
- Report Date
- April 7, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS MED-REL
- Product Code
- LZG
- PMA / PMN Number
- K031390
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP FAILED THE DISPLACEMENT TEST DUE TO AN OUT-OF-PHASE MOTOR ENCODER SIGNAL. NO MOTOR ERROR ALARMS WERE NOTED DURING REWIND.
Description of Event or Problem · 1
IT WAS REPORTED THAT A MOTOR ERROR ALARM OCCURRED DURING THE MANUAL PRIME. THE ALARM HISTORY SHOWED MULTIPLE MOTOR ERROR ALARMS. NOTHING FURTHER WAS REPORTED.
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-712WWB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |