BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1760943 · Received July 17, 2007

    Report

    Report Number
    1823260-2007-06192
    Event Type
    Malfunction
    Date Received
    July 17, 2007
    Date of Event
    June 26, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED OBTAINING BACK-TO-BACK BLOOD GLUCOSE RESULTS OF 361 MG/DL, 188 MG/DL, 144 MG/DL, AND 129 MG/DL ON THE ADVANTAGE SYSTEM. PATIENT DID NOT MODIFY THERAPY BASED ON THESE RESULTS. NO ADVERSE EVENT WAS REPORTED. QUALITY CONTROL TESTING HAD NOT BEEN PERFORMED ON THE SYSTEM. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING SYSTEM - LFR LFR ROCHE DIAGNOSTICS 549610

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO ASPIRIN 81 MG - ONCE DAILY| RANITIDINE 300 MG - ONCE DAILY| LANTUS 40 UNITS - 5 OR 6 YEARS| CRESTOR 10 MG - ONCE DAILY| QUININE SULFATE 325 MG - ONCE DAILY| NOVOLOG 7-12 UNITS - 5 OR 6 YEARS| FOLIC ACID 1 MG-ONCE DAILY| GLUCAGON, AS NEEDED - 1 MG| ALTACE 10 MG-ONCE DAILY| ONE-A-DAY| OMACOR 1 GRAM - TWICE DAILY