BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-712LNAB PRDGM INS BL EN US LN

    MDR report key: 1062680 · Received June 16, 2008

    Report

    Report Number
    2032227-2008-00989
    Event Type
    Malfunction
    Date Received
    June 16, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 6, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K031390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FAILED THE DISPLACEMENT TEST DUE TO AN OUT OF PHASE ENCODER SIGNAL.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT ESTIMATING THE RESERVOIR VOLUME AMOUNT CORRECTLY. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP DID NOT PASS THE DISPLACEMENT TEST. ADVISED THE CUSTOMER TO REVERT TO A BACK-UP PLAN AS THE INSULIN PUMP NEEDED TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-712LNAB PRDGM INS BL EN US LN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-712LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1