BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2063091 · Received April 11, 2011

    Report

    Report Number
    1826988-2011-00181
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 13, 2011
    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 EMAILED BAYER CUSTOMER SERVICE AND ONLY PROVIDED HER NAME. SHE DID NOT PROVIDE AN ADDRESS OR TELEPHONE NUMBER. PRODUCT CODE AND SERIAL NUMBER FOR THE METER WERE NOT PROVIDED. IT IS NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE OR 510K NUMBER WITHOUT THE METER INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER EMAILED CUSTOMER SERVICE AND ALLEGED SHE RECEIVED BLOOD GLUCOSE READINGS OF 92 AND 55 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE CONSENSUS ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. CUSTOMER SERVICE RESPONDED TO THE CUSTOMER'S EMAIL AND ASKED FOR HER PHONE NUMBER SO THAT SHE COULD BE CONTACTED. THERE HAS BEEN NO ADDITIONAL CONTACT FROM THE CUSTOMER. NO PRODUCT WILL BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK