BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1032041 · Received April 21, 2008

    Report

    Report Number
    1823260-2008-03400
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    April 8, 2008
    Report Date
    April 21, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THE OBTAINING A DISCREPANT BLOOD GLUCOSE RESULT OF HI (GREATER THAN 600 MG/DL) ON THE ADVANTAGE SYSTEM COMPARED BACK TO BACK WITH A RESULT OF 173 MG/DL ON THE DOCTOR'S SYSTEM WHEN TESTING WAS PERFORMED LESS THAN 10 MINUTES APART. REPORTER INDICATED THAT HE WAS NOT EXPERIENCING ANY HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF TESTING. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. 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 STIPS - LFR LFR ROCHE DIAGNOSTICS 550515

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR METFORMIN - TIME UNK 500MG TWICE DAILY