BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED SOF-SET ULTIMATE MMT 315

    MDR report key: 192741 · Received October 14, 1998

    Report

    Report Number
    MW1014788
    Event Type
    Malfunction
    Date Received
    October 14, 1998
    Date of Event
    September 29, 1998
    Report Date
    October 1, 1998
    Manufacturer
    MINIMED TECHNOLOGIES, INC.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAS TYPE 1 DIABETES. HE IS ON LISPRO INSULIN INFUSION VIA A MINIMED 507C INSULIN PUMP. HE CAME TO CLINIC 9/29/98 WITH HIS INFUSION SETS (MINIMED SOF-SET MMT 315, LOT NO 981085). PT BROUGHT WITH HIM A USED STYLET NEEDLE FROM A RECENTLY USED INFUSION SET. THE USED STYLET HAD A MARK & SLIGHT BEND IN IT. PT REPORTS THAT ON 6/18/98, A NEEDLE FROM THE SAME LOT BROKE, BUT FORTUNATELY THE BROKEN NEEDLE CAME OUT WITH THE INFUSION SET. HE STATES THAT ALL THE STYLETS HE HAS USED SINCE ENCOUNTERING THE BROKEN ONE HAVE BEEN FROM THE SAME LOT & HAVE APPEARED THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINIMED SOF-SET ULTIMATE MMT 315 INFUSION SET FMI MINIMED TECHNOLOGIES, INC. NA 981085

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other