BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 862276 · Received March 23, 2007

    Report

    Report Number
    1823260-2007-02356
    Event Type
    Malfunction
    Date Received
    March 23, 2007
    Date of Event
    April 1, 2006
    Report Date
    March 23, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE: COMFORT CURVE TEST STRIPS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY TESTED 75-85MG/DL ON THE ADVANTAGE TEST SYSTEM WHILE UNCONSCIOUS. CUSTOMER WAS GIVEN AN IV OF GLUCOSE BY PARAMEDICS TO ELEVATE THE BLOOD GLUCOSE. AT ANOTHER TIME, CUSTOMER REPORTEDLY OBTAINED RESULTS OF 57 MG/DL AND HI ON THE ADVANTAGE TEST SYSTEM WITHIN 10 MINUTES. CUSTOMER DRANK JUICE AFTER THE HI RESULT. NO ADVERSE EVENT REPORTED DUE TO THIS COMPARISON. NO QUALITY CONTROLS WERE USED. REQUESTED RETURN OF SUSPECT TEST SYSTEM AND REPLACEMENT WAS SENT. INFORMATION SUGGESTS BOTH INCIDENTS OCCURRED IN THE HOME. ADVANTAGE TEST SYSTEM: TEST STRIP LOT 549202, EXP 9/30/07, CAT/2030365.

    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 * 549202

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR CATOPRIL - 6-7 YRS 50MG, 1 1/2 PILLS, 2X| AVANDIA - 7 YRS 8MG, 1X DAY| GLIPIZIDE - 6-7 YRS 5MG, 2X DAY| NEURONTIN - 3 YRS 400MG, 2 PILLS 3X DAY| TRIAMTERENE - 2 YRS 37.5/25 1X DAY