BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1212739 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01187
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    September 30, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE HAD RECEIVED SOME CONTROL TEST RESULTS THAT WERE HIGH, OUT OF SPECIFICATION. WHILE TROUBLESHOOTING, SHE PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 395 AND 334 MG/DL. THE NORMAL CONTROL RANGE WAS 94-130 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC NOT PROVIDED 6MC3B06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK