BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761228 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06405
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    July 8, 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
    PA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED HAVING DISCREPANT BACK TO BACK BLOOD GLUCOSE RESULTS OF 394, 347, 143, & 195MG/DL WHEN ALL TESTS WERE PERFORMED ON THE ADVANTAGE SYSTEM. REPORTER DID NOT INDICATE A SPECIFIC TIMEFRAME BETWEEN TESTS OTHER THAN THE REFERENCE TO BACK TO BACK. REPORTER STATED SHE WAS NO EXPERIENCING ANY HYPERGLYCEMIC SYMPTOMS DURING THE TIME OF THE TESTING. NO ACTIONS WERE TAKEN OR TREATMENT REPORTED 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 DEVICE - LFR LFR ROCHE DIAGNOSTICS 549711

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR COUMADIN 3YRS - 2.5-5MG ONCE DAILY| ASPIRIN - 81MG ONCE DAILY| LASIX - 40MG ONCE DAILY| GLUCOPHAGE 1YR - 2MG TWICE DAILY| VYTORIN 6MOS - 10-20MG ONCE DAILY| DIGITEK - 125MG ONCE DAILY| METOPROLOL - 25MG TWICE DAILY| AMIODARONE - 200MG ONCE DAILY