BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512NAS PRDGM INSULIN SK EN

    MDR report key: 1092124 · Received July 31, 2008

    Report

    Report Number
    2032227-2008-01324
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 21, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF THE INSULIN PUMP ALARMING MOTOR ERROR. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP FAILED THE DISPLACEMENT TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-512NAS PRDGM INSULIN SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-512NAS

    Patients

    Seq Age Sex Outcome Treatment
    1