BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1071490 · Received July 2, 2008

    Report

    Report Number
    1826988-2008-00748
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR HELP WITH HIS NEW CONTOUR METER. WHILE TROUBLESHOOTING, THE CUSTOMER ALLEGED THAT HE RECEIVED A BLOOD GLUCOSE READING OF 2.3 MMOL/L. THE METER IN QUESTION SHOULD HAVE THE UNITS OF MEASURE LOCKED IN MG/DL. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. THE METER IS TO BE RETURNED FOR EVAL. A NEW CONTOUR METER KIT WAS SENT TO THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK