BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1770590 · Received October 25, 2007

    Report

    Report Number
    1823260-2007-09330
    Event Type
    Malfunction
    Date Received
    October 25, 2007
    Date of Event
    October 2, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS OBTAINING DISCREPANT BLOOD GLUCOSE RESULT OF 424 MG/DL BACK TO BACK WITH A BLOOD GLUCOSE RESULT OF 187 MG/DL WHEN TESTS WERE PERFORMED WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM. CUSTOMER STATED USING 2 DIFFERENT TEST STRIP VIALS WITH THE SAME LOT NUMBERS FOR EACH READING. IT WAS STATED A THIRD BLOOD GLUCOSE TEST OF 283 MG/DL WAS OBTAINED WITHIN 10 MINUTES ON THE SAME SYSTEM USING THE TEST STRIP VIAL THE RESULT OF 424 MG/DL WAS GENERATED. CUSTOMER STATED NO HYPOGLYCEMIC OR HYPERGLYCEMIC SYMPTOMS WERE EXPERIENCED. NO ACTION OR TREATMENT WAS REPORTED BY CUSTOMER. 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 549821

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR METFORMIN - 5 MONTHS - 500MG TWICE DAILY AM/PM| XYLANTAN - SEVERAL YEARS - 1 DROP IN EACH EYE, PM| ZETIA - 6 MONTHS - 10MG DAILY PM| ECOTRIN - 6 YEARS - 325MG DAILY AM| SPIRONOLACTONE - 6 MONTHS - 25MG DAILY PM| ALLOPURINOL - MANY YEARS - 300MG DAILY AM| LISINOPRIL/HCT - 6 MONTHS - 20/25MG DAILY AM| COSOPT- SEVERAL YRS - 1 DROP RIGHT EYE AM, LEFT PM