BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2. BL EN

    MDR report key: 1241039 · Received November 21, 2008

    Report

    Report Number
    3004209178-2008-00980
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 1, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY, AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 395 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER HAD AN INFECTION AND A VIRUS AT THE TIME OF THE EVENT, WHICH CONTRIBUTED TO THE ELEVATED BLOOD GLUCOSE LEVELS. HOWEVER, THE CUSTOMER'S BLOOD GLUCOSE LEVELS REMAINED HIGH AFTER THE EVENT. THE PRIME AND HIGH PRESSURE TESTS PASSED. NOTHING FURTHER WS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAB PRDGM INS V2.2. BL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization