FDA Adverse Event
Malfunction
Summary report: N
PUMP MMT-722NAL PRDGM INSULIN CL EN
MDR report key: 1062679
·
Received June 16, 2008
Report
- Report Number
- 2032227-2008-00988
- Event Type
- Malfunction
- Date Received
- June 16, 2008
- Date of Event
- May 23, 2008
- Report Date
- April 2, 2008
- Manufacturer
- MEDTRONIC MINIMED
- Product Code
- LZG
- PMA / PMN Number
- P980022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE INSULIN PUMP GAVE ERROR ALARMS AND FAILED THE DISPLACEMENT TESTS DUE TO AN OUT OF PHASE MOTOR ENCODER SIGNAL.
Description of Event or Problem · 1
THE CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP WAS GIVING ERROR ALARMS. TROUBLESHOOTING REVEALED THAT THE INSULIN PUMP NEEDED TO BE REPLACED. ADVISED THE CUSTOMER TO REVERT TO A BACK-UP PLAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PUMP MMT-722NAL PRDGM INSULIN CL EN | INFUSION PUMP | LZG | MEDTRONIC MINIMED | MMT-722LNAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |