BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1937517 · Received December 20, 2010

    Report

    Report Number
    1826988-2010-00856
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K060470
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HIS BLOOD GLUCOSE USING ONE OF HIS CONTOUR METERS AND RECEIVED READINGS OF 425, 478, 378 AND 160 MG/DL. HIS 2 OTHER CONTOUR METERS GAVE READINGS OF 274, 153, 161, 227, 144, 262, 326 AND 246 MG/DL. THE DIFFERENCE BETWEEN SOME OF THE 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 NBW BAYER HEALTHCARE LLC 7151 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK