BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2438539 · Received February 3, 2012

    Report

    Report Number
    1826988-2012-00010
    Event Type
    Malfunction
    Date Received
    February 3, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 4, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT INFORMATION WAS NOT OBTAINED DURING THE CALL. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE OR 510K NUMBER WITHOUT THE METER INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED REGARDING THE BLOOD GLUCOSE READINGS SHE HAD RECEIVED USING HER 2 CONTOUR METERS. THE READINGS WERE 210, 150 AND 97 MG/DL. IT'S NOT KNOWN WHICH READING(S) CAME FROM WHICH METER, BUT THE DIFFERENCE BETWEEN THE 210 AND 97 MG/DL READINGS FALLS IN THE "C" " ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENT WAS ALLEGED. CONTROL SOLUTION WAS SENT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1