BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 1982557 · Received January 11, 2011

    Report

    Report Number
    1826988-2010-00877
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED FOR ASSISTANCE WITH PERFORMING A CONTROL TEST USING HER CONTOUR SYSTEM. SHE PERFORMED 2 CONTROL TESTS DURING THE CALL AND REC'D READINGS OF "LO" AND 432 MG/DL. THE NORMAL CONTROL RANGE WAS 109-150 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER DID NOT HAVE ANY TEST STRIPS LEFT TO RETURN FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR NBW BAYER HEALTHCARE LLC 9556C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK