BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR USB

    MDR report key: 2072617 · Received April 25, 2011

    Report

    Report Number
    1826988-2011-00209
    Event Type
    Malfunction
    Date Received
    April 25, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 27, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K091820
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ADVOCATE ALLEGED A CONTROL TEST WAS PERFORMED USING THE CUSTOMER'S CONTOUR USB SYSTEM AND THE RESULT WAS 350 MG/DL. THE NORMAL CONTROL RANGE WAS 106-146 MG/DL. IT WAS NOT POSSIBLE TO TROUBLESHOOT DURING THE INITIAL CALL. CUSTOMER SERVICE ATTEMPTED TO CONTACT THE CUSTOMER OR ADVOCATE AFTER THE INITIAL CALL, BUT IT WAS NOT POSSIBLE TO SPEAK WITH EITHER OF THEM. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR USB NBW BAYER HEALTHCARE, LLC 7390 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK