BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAL PRDGM INSULIN CL EN

    MDR report key: 1142783 · Received August 27, 2008

    Report

    Report Number
    2032227-2008-01479
    Event Type
    Malfunction
    Date Received
    August 27, 2008
    Date of Event
    August 16, 2008
    Report Date
    August 16, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REPORTED THAT SHE WAS HOSPITALIZED DUE TO AN INFECTION AND HYPERGLYCEMIA. THE CUSTOMER STATED THAT SHE HAD FOUR CANNULAS IN A ROW THAT CAME OUT OF HER BODY BENT, CONTRIBUTING TO THE HIGH BLOOD GLUCOSE LEVELS, BUT THE INSULIN PUMP NEVER ALARMED NO DELIVERY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP FAILED THE HIGH PRESSURE TEST. THE HIGH PRESSURE TEST WAS REPEATED TWO MORE TIMES WITH DIFFERENT INFUSION SETS AND RESERVOIRS, AND THE INSULIN PUMP FAILED THE TEST BOTH TIMES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INSULIN CL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1