BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1192425 · Received October 7, 2008

    Report

    Report Number
    2032227-2008-01744
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 20, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED ROR HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING WAS 350MG/DL AT TIME OF THE CALL. TROUBLESHOOTING WAS PERFORMED, AND THE BASAL RATES AND SETTINGS IN THE INSULIN PUMP WERE CORRECT. CUSTOMER'S MOTHER STATED THAT THE INSULIN PUMP BUTTONS WERE UNRESPONSIVE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization