BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 491437 · Received October 24, 2003

    Report

    Report Number
    2032227-2003-01086
    Event Type
    Injury
    Date Received
    October 24, 2003
    Date of Event
    September 26, 2003
    Report Date
    September 26, 2003
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PUMP HAD ALARMS. TROUBLESHOOTING WAS PERFORMED, IT WAS FOUND THAT THE ALARM HAS BEEN OCCURRING FOR WEEKS. SEVERAL DAY LATER A DIABETES EDUCATOR REPORTED THAT THE CUSTOMER WAS ADMITTED TO THE HOSPITAL FOR HIGH BLOOD GLUCOSE. THE PUMP PASSED THE SELF-TEST. HOWEVER, IT WAS INFORMED THAT THE CUSTOMER HAD SURGERY FEW DAYS BEFORE THE CALL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization