BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROCHE DISETRONIC MEDICAL SYSTEMS AG

    MDR report key: 697926 · Received April 4, 2006

    Report

    Report Number
    MW1038418
    Event Type
    Injury
    Date Received
    April 4, 2006
    Date of Event
    April 2, 2006
    Report Date
    April 4, 2006
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PROBLEM WITH THE ACCU-CHEK ULTRAFLEX INSULIN INFUISON SET. ON THE MORNING OF 04/02/06, I PUT IN A BRAND NEW INFUSION SET. THE ADHESIVE WAS DEFECTIVE BUT I DID NOT REALIZE IT UNTIL FOUR HOURS LATER WHEN MY BLOOD GLUCOSE LEVELS WERE TOO HIGH. WHEN I CHECKED THE INFUSION SET IT WAS COMPLETELY OFF THE INFUSION SITE SO THAT I HAD NOT BEEN RECEIVING INSULIN FROM MY INSULIN PUMP FOR AN UNDETERMINED AMOUNT OF TIME. WHEN I DISCOVERED THE PROBLEM I IMMEDIATELY PUT IN ANOTHER INFUSION SET AND HAD TO GIVE MASSIVE DOSES OF INSULIN WITH MY INSULIN PUMP OVER SEVERAL HOURS TO COMPENSATE FOR THE LACK OF INSULIN ON BOARD. EVEN THE NEXT DAY MY BLOOD GLUCOSE CONTROL WAS NOT CONSISTENT DUE TO THE LACK OF INSULIN DELIVERY FROM THE DEFECTIVE INFUSION SET. THE INSULIN INFUSION SET IS SUPPOSED TO LAST THREE DAYS AND THEN IT IS REMOVED AND DISCARDED. THIS ONE LASTED FOR MUCH LESS THAN FOUR HOURS DUE TO THE ADHESIVE MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROCHE DISETRONIC MEDICAL SYSTEMS AG ACCU-CHEK ULTRAFLEX SET FPA DISETRONIC MEDICAL SYSTEMS, INC 10/110 5D219UF

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other