BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (10)

    MDR report key: 1012911 · Received March 11, 2008

    Report

    Report Number
    1826988-2008-00272
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE PERFORMED CONTROL TESTS AND RECEIVED SOME LOW RESULTS. SHE PERFORMED 2 MORE CONTROL TESTS WHILE TROUBLESHOOTING AND RECEIVED RESULTS OF 42 AND 57 MG/DL. THE NORMAL CONTROL RANGE WAS 100-139 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS AND METER ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT PRODUCTS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (10) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 9507B 7DC3C51

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK