BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761217 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06410
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 1, 2007
    Report Date
    July 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE VALUES IN THE 300S MG/DL BACK TO BACK WITH A RESULT IN THE 100S MG/DL WHEN TESTING WAS PERFORMED ON THE ADVANTAGE SYSTEM. REPORTER DID NOT PROVIDE THE EXACT TIME BETWEEN THE TESTINGS OTHER THAN THE REFERENCE TO BACK TO BACK TESTING. REPORTER STATED SHE WAS EXPERIENCING HYPOGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING AND TOOK INSULIN BASED ON THE RESULT; HOWEVER, COULD NOT VERIFY WHAT KIND OF TREATMENT, IF ANY, SHE RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE AND REPLACEMENT PRODUCT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA INSULIN PUMP - UNKNOWN DOSAGE