BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ACTIVE TEST STRIPS

    MDR report key: 1061051 · Received June 13, 2008

    Report

    Report Number
    1823260-2008-04708
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K021827
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS BACK TO BACK BLOOD GLUCOSE RESULTS OF LO (LESS THAN 10 MG/DL) AND 10 MG/DL OBTAINED ON THE ACTIVE SYSTEM WITH NO LOW BLOOD GLUCOSE SYMPTOMS. CUSTOMER SELF TREATED WITH 6 OZ MILK & AN ORANGE, AND RE-TESTED WITHIN 10 MINUTES AND RESULT WAS 118 MG/DL. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ACTIVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 22978432

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK