BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 669789 · Received September 8, 2005

    Report

    Report Number
    1823260-2005-02639
    Event Type
    Malfunction
    Date Received
    September 8, 2005
    Date of Event
    August 24, 2005
    Report Date
    August 24, 2005
    Manufacturer
    ROCHE DIAGNOSTICS CORP.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    LAST THREE DIGITS OF TEST STRIP VIAL LOT NUMBER IS SMUDGED. NO OTHER INFORMATION WAS GIVEN. A REQUEST WAS MADE FOR RETURN PRODUCT AND REPLACEMENT PRODUCT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING SYSTEM CFR ROCHE DIAGNOSTICS CORP. NA 548579

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN