BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 1012916 · Received March 11, 2008

    Report

    Report Number
    1826988-2008-00266
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 19, 2008
    Report Date
    February 19, 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 METER OR TEST STRIPS WITH HIM AT THE TIME OF THE CALL. WITHOUT A SERIAL NUMBER OR LOT NUMBER IT IS NOT POSSIBLE TO DETERMINE A MFR DATE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HE PERFORMED A CONTROL TEST AND RECEIVED A RESULT OF 239 MG/DL. THE NORMAL CONTROL RANGE WAS 100-138 MG/DL. THE CUSTOMER DID NOT HAVE HIS METER, OR SUPPLIES WITH HIM AT THE TIME OF THE CALL, SO 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 7151B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK