BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1781053 · Received July 25, 2007

    Report

    Report Number
    1823260-2007-06509
    Event Type
    Malfunction
    Date Received
    July 25, 2007
    Date of Event
    July 11, 2007
    Report Date
    July 25, 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

    CUSTOMER ALLEGED BLOOD GLUCOSE RESULTS OF HI (GREATER THAN 600 MG/DL) AND 166 MG/DL WHEN TESTING WAS PERFORMED WITHIN 10 MINS ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED HAVING NO SYMPTOMS AND DID TREAT/ACT BASED ON RESULTS. NO ADVERSE EVENT WAS REPORTED IN CONNECTION WITH THE DISCREPANCY. 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 549716

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR LISINOPRIL - 20MG BEDTIME| LANTUS - 2.5 MONTHS - 10UNITS DAILY| LESCOL XL - 80MG DAILY| CALCIUM 800D - DAILY| CARBAMAZEPINE - 200MG TWICE DAILY| SEROQUEL - 150MG DAILY| CLONAZEPAM - 4MG BEDTIME| ASPIRIN - 81MG DAILY| FLUOXETINE - 20MG DAILY| VITAMIN D - 800MG DAILY| PRANDIN - 2.5 MONTHS - 0.5MG THRICE DAILY