BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1761229 · Received July 23, 2007

    Report

    Report Number
    1823260-2007-06408
    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
    KY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING DISCREPANT BLOOD GLUCOSE VALUES OF 88MG/DL BACK TO BACK WITH A RESULT OF 180MG/DL WHEN TESTING WAS PERFORMED 2 MINUTES APART ON THE ADVANTAGE SYSTEM. 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 TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 549618

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR GLYBURIDE 4MOS - 5MG TWICE DAILY| SIMVASTATIN 2YRS - 40MG/0.5 TAB ONCE DAILY| ETODOLAC 3MOS - 400MG TWICE DAILY| METFORMIN 4MOS - 500MG TWICE DAILY| HYDROCHLOROTHIAZIDE 3YRS - 2MG ONCE DAILY