BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 499661 · Received December 8, 2003

    Report

    Report Number
    2032227-2003-01351
    Event Type
    Injury
    Date Received
    December 8, 2003
    Date of Event
    November 9, 2003
    Report Date
    November 10, 2003
    Manufacturer
    MINIMED, INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD SUGAR LEVELS. THE CUSTOMER HAD BEEN EXPERINCING HBG'S FOR THE PAST THREE DAYS. THE PROGRAMMING ON THE PUMP WAS ACCURATE AND IT PASSED THE LEADSCREW TEST. IT WAS INDICATED THAT THE CAUSE FOR HBG WAS UNDEFINED. THE CUSTOMER WILL CALL BACK TO FINISH FURTHER TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUSION PUMP INFUSION PUMP LZG MINIMED, INC. MMT-508UW NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization