BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1743624 · Received June 28, 2007

    Report

    Report Number
    1823260-2007-05631
    Event Type
    Malfunction
    Date Received
    June 28, 2007
    Date of Event
    June 5, 2007
    Report Date
    June 28, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    STRIP LOT 549081 IS REPORTED IN MEDWATCH (B)(6).

    Description of Event or Problem · 1

    CUSTOMER ALLEGED DISCREPANT BLOOD GLUCOSE RESULTS OF 45 MG/DL, 44 MG/DL, 44 MG/DL, AND 41 MG/DL WITH TEST STRIP LOT 549081 AND 81 MG/DL, 82 MG/DL, 122 MG/DL, 119 MG/DL, 66 MG/DL, 59 MG/DL AND 92 MG/DL WITH TEST STRIP LOT 549435 WHEN EACH TEST WAS PERFORMED WITHIN 1 MINUTE OF THE PREVIOUS TEST ON THE ADVANTAGE SYSTEM. CUSTOMER REPORTED HAVING LOW GLUCOSE SYMPTOMS AND TREATED WITH 12 OZ (B)(4), GLASS OF MILK, AND 3 SLICES OF BREAD WHILE TESTING. CUSTOMER REPORTED FEELING BETTER IN 10-15 MINUTES. NO ADVERSE EVENT WAS 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 STRIPS - LFR LFR ROCHE DIAGNOSTICS 549435

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR GLYBURIDE - 15 YEARS, 2.5MG DAILY| METFORMIN - < 1 MONTH, 500MG 4 TIMES DAILY