BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE

    MDR report key: 675879 · Received February 10, 2006

    Report

    Report Number
    1823260-2006-00617
    Event Type
    Malfunction
    Date Received
    February 10, 2006
    Date of Event
    January 14, 2006
    Report Date
    January 14, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CFR
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE STRIP VIAL EXPIRATION DATE IS LISTED AS 07/31/2006; HOWEVER, ACCORDING TO MANUFACTURER'S ELECTRONIC INVENTORY SYSTEM, THE CORRESPONDING LOT NUMBER EXPIRED 07/31/2003. ADDITIONALLY, PATIENT REPORTED THAT THE STRIP CATALOG NUMBER IS LISTED AS 6000141. THE CORRECT CATALOG NUMBER SHOULD BE 3000141. PATIENT NOTED THAT THE LABEL'S INK HAS NOT SMEARED AND THE BOX WAS SEALED WHEN PURCHASED FROM THE PHARMACY. TECHNICAL SUPPORT REQUESTED THE RETURN OF THE SUSPECT PRODUCT AND REPLACEMENT PRODUCT WAS SHIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE BLOOD GLUCOSE MONITORING DEVICE CFR ROCHE DIAGNOSTICS NA 545786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA