BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1081756 · Received July 18, 2008

    Report

    Report Number
    2032227-2008-01251
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    July 14, 2008
    Report Date
    June 1, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING REWIND, AND THE DEVICE FAILED THE DISPLACEMENT TEST. PROBLEM ISOLATED TO THE MOTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 86 MG/DL. TROUBLESHOOTING WAS PERFORMED. ADVISED CUSTOMER TO DISCONTINUE USING THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1