BEUDAMED
    FDA Adverse Event Other Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 347176 · Received August 13, 2001

    Report

    Report Number
    2032227-2001-00034
    Event Type
    Other
    Date Received
    August 13, 2001
    Date of Event
    July 21, 2001
    Report Date
    July 21, 2001
    Manufacturer
    MINIMED INC.
    Product Code
    LZG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    A STAFF NURSE CALLED TO REPORT THAT THE CUSTOMER WAS HOSPITALIZED TWICE WITH HIGH BLOOD GLUCOSE. THE CUSTOMER COMPLAINED OF NAUSEA AND SYMPTOMS OF DKA. SHE STATED THE CUSTOMER WAS ON INSULIN DRIPS FOR HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. PUMP TEST OK. DAILY TOTALS, BASAL TOTALS AND BOLUS HISTORY WERE CORRECT IN THE PUMP. CUSTOMER CALLED BACK AGAIN FROM THE HOSPITAL TO REQUEST A REPLACEMENT PUMP. TROUBLESHOOTING WAS PERFORMED FOR THE SECOND TIME. THE DEVICE PASSED THE TEST AND WAS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36542 MINIMED INFUSION PUMP INFUSION PUMP LZG MINIMED INC. MMT-508UC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization