BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1477481 · Received July 10, 2009

    Report

    Report Number
    1826988-2009-00602
    Event Type
    Malfunction
    Date Received
    July 10, 2009
    Date of Event
    June 23, 2009
    Report Date
    June 23, 2009
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE A METER SERIAL NUMBER, SO IT WAS NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT HE WAS RECEIVING ERRATIC READINGS BETWEEN HIS 2 COUNTER METERS. THE READING EXAMPLES HE PROVIDED WERE 202, 111, 147, 133, 144, 109, 139, 121, 200, 115, 144, AND 83 MG/DL. IT'S NOT KNOWN WHICH READINGS CAME FROM WHICH METER. THE DIFFERENCE BETWEEN SOME OF THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. CUSTOMER SERVICE OFFERED TO TROUBLESHOOT THE CONTOUR SYSTEMS, BUT THE CUSTOMER BECAME UPSET AND ENDED THE CALL. NO PRODUCT WILL BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK