BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-515PNAP PRDGM INS PL EN US PW

    MDR report key: 1070367 · Received June 30, 2008

    Report

    Report Number
    2032227-2008-01094
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 12, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED. RAN A DISPLACEMENT TEST AND THE DEVICE FAILED THE TEST. THE BLOOD GLUCOSE READING WAS 411MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515PNAP PRDGM INS PL EN US PW INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515PNAP

    Patients

    Seq Age Sex Outcome Treatment
    1