BEUDAMED
    FDA Adverse Event Summary report: N

    ASCENSIA CONTOUR

    MDR report key: 834116 · Received March 7, 2007

    Report

    Report Number
    1826988-2007-00104
    Date Received
    March 7, 2007
    Date of Event
    February 10, 2007
    Report Date
    February 10, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER FOR THE OTHER CONTOUR METER IS 5252059. IT HAS THE SAME PRODUCT AND A MANUFACTURER DATE OF 12/2005.

    Description of Event or Problem · 1

    THE CONTACT STATED THE CUSTOMER TESTED HER BLOOD GLUCOSE USING 2 CONTOUR METERS AND RECEIVED READINGS OF 15.1 AND 13.8 MMOL/L. HE STATED THAT SHE HAD BEEN FASTING FOR 12 HOURS PRIOR TO TESTING HER GLUCOSE. THE CUSTOMER PERFORMED 2 MORE BLOOD GLUCOSE TESTS WHILE TROUBLESHOOTING AND RECEIVED READINGS OF 15.1 AND 29.5 MMOL/L. THE CONTACT WAS IRATE AND UNCOOPERATIVE. HE REFUSED TO PROVIDE ANY INFORMATION ABOUT WHETHER THE CUSTOMER HAD EXPERIENCED ANY ADVERSE EVENTS. THE CONTACT WAS ADVISED TO SEEK MEDICAL ATTENTION IF THE CUSTOMER FELT ILL IN ANY WAY. THIS COMPLAINT IS TO BE REPORTED PER BAYER'S POLICY AS THE CONTACT THREATENED LEGAL ACTION, EVEN THOUGH THERE WAS NO INDICATION OF A PRODUCT PROBLEM OR ADVERSE EVENT. THE CONTACT ENDED THE CALL AND IT DOESN'T APPEAR THAT THE METERS 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 7152 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR