BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 519880 · Received April 8, 2004

    Report

    Report Number
    2032227-2004-00541
    Event Type
    Injury
    Date Received
    April 8, 2004
    Date of Event
    March 9, 2004
    Report Date
    March 9, 2004
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPERGLYCEMIA. THE CUSTOMER HAD BEEN EXPERIENCING UNEXPLAINED HBGS. IT WAS CONFIRMED THAT THE PROGRAMMING AND HISTORIES WERE ACCURATE. TROUBLESHOOTING WAS DONE AND THE PUMP PASSED THE FUNCTIONAL TESTS. THE CUSTOMER WAS ADVISED TO DISCUSS POSSIBLE CAUSES OF HBG WITH MD AND TO FOLLOW THE TWO HBG RULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUSION PUMP INFUSION PUMP LZG MINIMED INC. MMT-511LNAS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization