BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 805670 · Received January 3, 2007

    Report

    Report Number
    1823260-2007-00059
    Event Type
    Malfunction
    Date Received
    January 3, 2007
    Date of Event
    December 11, 2006
    Report Date
    January 3, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER STATES RECEIVING DISCREPANT B2B RESULTS ON 12/11/2006: 76 MG/DL (17:12), 35 MG/DL (17:18), 33 MG/DL (17:20). NO TREATMENT WAS GIVEN BASED ON THE RESULTS. CONTROLS WERE RUN AND WERE WITHIN RANGE; HOWEVER, CUSTOMER IS UNSURE IF SAME VIAL WAS TESTED. REQUEST WAS MADE FOR THE RETURN OF THE DEVICE AND A REPLACEMENT 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 * 549501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NOT PROVIDED