BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 351590 · Received September 12, 2001

    Report

    Report Number
    2032227-2001-00079
    Event Type
    Malfunction
    Date Received
    September 12, 2001
    Date of Event
    August 11, 2001
    Report Date
    August 15, 2001
    Manufacturer
    MINIMED, INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS HOSPITALIZED IN 2001. CUSTOMER WAS ADMITTED FOR DKA, WITHIN 24 HOURS CUSTOMER WAS FEELING BETTER AND THE DOCTOR PUT CUSTOMER BACK ON THE PUMP. WHILE CUSTOMER WAS ON THE PUMP, CUSTOMER WENT BACK INTO DKA AGAIN. THIS IS A REPLACEMENT PUMP. LEAD SCREW TEST WAS PERFORMED WITHOUT A RESERVOIR ON THE PUMP. LEAD SCREW MADE ONE COMPLETE ROTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41653 MINIMED INFUSION PUMP INFUSION PUMP LZG MINIMED, INC. MMT-508UC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization