BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1082807 · Received July 24, 2008

    Report

    Report Number
    1826988-2008-00798
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 29, 2008
    Report Date
    June 29, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT HAVE HIS CONTOUR METER OR TESTING SUPPLIES WITH HIM AT THE TIME OF THE CALL, SO IT WAS NOT POSSIBLE TO OBTAIN THE METER SERIAL NUMBER OR THE REAGENT LOT NUMBER. WITHOUT A SERIAL OR LOT NUMBER, IT IS NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED ALLEGED THAT HE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 254 MG/DL. THE NORMAL CONTROL RANGE WAS 102-141 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DID NOT HAVE HIS METER OR TESTING SUPPLIES WITH HIM AT THE TIME OF THE CALL, SO FURTHER TROUBLESHOOTING WAS NOT POSSIBLE. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    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 UNK