BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED INFUSION PUMP

    MDR report key: 376637 · Received February 11, 2002

    Report

    Report Number
    2032227-2002-00033
    Event Type
    Malfunction
    Date Received
    February 11, 2002
    Date of Event
    December 20, 2001
    Report Date
    December 20, 2001
    Manufacturer
    MEDTRONIC MINIMED, INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT WHILE THE CUSTOMER WAS TRYING TO PROGRAM A BOLUS, THE CUSTOMER'S PUMP SKIPPED PAST THE BOLUS SCREEN. IT WAS ALSO STATED THAT IN ORDER TO PROGRAM A BOLUS THE CUSTOMER HAD TO SET THE TIME BACK BY ONE MINUTE AND THEN RUN A SELF-TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED INFUSION PUMP INFUSION PUMP LZG MEDTRONIC MINIMED, INC. MMT-507CUC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR