BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-512LWWB PRDGM INS BL EN LN

    MDR report key: 1201861 · Received October 15, 2008

    Report

    Report Number
    2032227-2008-01795
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K030531
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. IT WAS REPORTED THAT WHILE AT THE HOSPITAL, THE CUSTOMER'S BLOOD GLUCOSE LOWERED WHILE ON AN INSULIN INFUSION, BUT WHEN THE CUSTOMER WAS PLACED BACK ON THE INSULIN PUMP HIS BLOOD GLUCOSE LEVELS ELEVATED AGAIN. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization