BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK COMPACT TEST DRUM

    MDR report key: 1032525 · Received April 22, 2008

    Report

    Report Number
    1823260-2008-03454
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS HE HAD A READING IN THE 500'S MG/DL WHILE USING THE COMPACT SYSTEM. CUSTOMER WAS USING EXPIRED STRIPS. CUSTOMER REPORTS HE DROVE TO THE HOSPITAL AND WAS GIVEN AN IV OF UNKNOWN CONTENT. NO QUALITY CONTROLS WERE RUN. CUSTOMER WAS RELEASED FROM THE HOSPITAL 8-8 1/2 HOURS LATER. A REQUEST WAS MADE FOR RETURN OF THE SUSPECT PRODUCT AND A REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMPACT TEST DRUM BLOOD GLUCOSE MONITORING STRIPS - LFR LFR ROCHE DIAGNOSTICS 20645641

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention DIABETES MED 750MG 2X/DAY - UNK