BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-512NAB PRDGM INSULIN BL EN

    MDR report key: 1150034 · Received August 27, 2008

    Report

    Report Number
    2032227-2008-01468
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 COMPLAINED OF HIGH BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE LEVEL WAS 375 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE PRIME TEST. THE PRIME TEST WAS PERFORMED A SECOND TIME WITH A NEW RESERVOIR AND INFUSION SET, AND THE INSULIN PUMP PASSED. HOWEVER, THE INSULIN PUMP FAILED THE HIGH PRESSURE TEST TWICE. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1