BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 2556314 · Received April 24, 2012

    Report

    Report Number
    1826988-2012-00195
    Event Type
    Malfunction
    Date Received
    April 24, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 23, 2012
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVED CONTROL RESULTS OF 31 AND 30 MG/DL PRIOR TO THE PHONE CALL AND A 41MG/DL DURING THE CALL. RANGE IS 102-140 MG/DL. NO ADVERSE EVENTS ALLEGED. CUSTOMER STRIPS WERE REPLACED AND SHE IS EXPECTED TO RETURN HER STRIPS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS NBW BAYER HEALTHCARE LLC 7098C 1DC3801C

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK