BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 722463 · Received June 2, 2006

    Report

    Report Number
    1826988-2006-00557
    Event Type
    Malfunction
    Date Received
    June 2, 2006
    Date of Event
    May 5, 2006
    Report Date
    May 5, 2006
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    METER WAS GIVING LOE BLOOD GLUCOSE READINGS. UPON TROUBLESHOOTING, IT WAS DISCOVERED THE METER WAS SET IN MMOL/L. THE CUSTOMER DID NOT ADJUST MEDICATION OR ALLEGE ANY ADVERSE EVENT DUE TO THE MMOL/L READINGS. THE CUSTOMER WAS ABLE TO RESET THE METER TO MG/DL WITH ASSISTANCE, AND NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 7151 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN