BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOF-SET IV SET

    MDR report key: 29578 · Received January 30, 1996

    Report

    Report Number
    MW1008221
    Event Type
    Injury
    Date Received
    January 30, 1996
    Date of Event
    January 1, 1991
    Report Date
    January 30, 1996
    Manufacturer
    MINIMED TECHNOLOGIES
    Product Code
    FOZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER STARTED USING BOTH PRODUCTS IN JULY OF 1991. ACCORDING TO RPTR, THE IV SET DELIVERED ONLY HALF OF THE INSULIN DOSE IN OCTOBER OF 1991, CAUSING HER TO HAVE DKA. HER BLOOD GLUCOSE WAS 497. THIS EPISODE OF DKA CAUSED HER TO HAVE A STROKE, WHICH WAS DIAGNOSED BY MRI, AND SUBSEQUENT MEMORY LOSS. SHE HAD COPIOUS AMOUNTS OF KETONE IN HER BLOOD. RPTR CONTINUED TO EXPERIENCE FAILURE OF THE PUMP WHICH WAS REPLACED 7 TIMES BY THE MFR. THE LAST PROBLEM RPTR HAD WAS IN JANUARY OF 1996, WHEN THE PUMP WENT COMPLETELY BLANK. THE RPTR TRIED TROUBLESHOOTING AS DIRECTED BY THE MFR'S REP, HOWEVER, NOTHING WORKED. SHE WAS TOLD BY THE REP THAT THE CAUSE OF FAILURE COULD BE ELECTROSTATIC MALFUNCTION. THREE DAYS LATER, WHEN THE PUMP WAS SITTING IN THE BATHROOM, IT CAME BACK ON. RPTR IS VERY CONCERNED THAT THE PUMP MIGHT FAIL ANY TIME. IT IS ALSO OUT OF WARRANTY. (ALSO SEE 1008220)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOF-SET IV SET IV SET FOZ MINIMED TECHNOLOGIES 5045

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R