BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522LNAP PRDGM INS PL EN ML

    MDR report key: 1162802 · Received September 8, 2008

    Report

    Report Number
    2032227-2008-01524
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 21, 2008
    Report Date
    August 21, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP, AND TO REVERT TO A BACKUP PLAN TO TREAT HER DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAP PRDGM INS PL EN ML INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR