BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 2222372 · Received July 15, 2011

    Report

    Report Number
    1826988-2011-00410
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT HAVE HER PRODUCTS WITH HER AT THE TIME OF THE CALL, SO PRODUCT INFO COULD BE OBTAINED. IT'S NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE OR 510K NUMBER W/O THE METER/PRODUCT INFO.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE PERFORMED A CONTROL TEST USING HER CONTOUR SYSTEM AND REC'D A RESULT OF 456 MG/DL. THE NORMAL CONTROL RANGE COULD NOT BE PROVIDED, BUT SHOULD BE AROUND 106-147 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DID NOT HAVE HER SUPPLIES WITH HER AT THE TIME OF THE CALL. CUSTOMER SERVICE ATTEMPTED TO CONTACT THE CUSTOMER AFTER THE INITIAL CALL, BUT THEY WERE UNABLE TO SPEAK TO HER. 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