BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROFILL TEST STRIPS (50)

    MDR report key: 864217 · Received September 27, 2006

    Report

    Report Number
    1826988-2006-01159
    Event Type
    Malfunction
    Date Received
    September 27, 2006
    Date of Event
    August 22, 2006
    Report Date
    August 22, 2006
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONTACT STATED THAT, THE CUSTOMER'S GLUCOSE READINGS HAVE BEEN HIGHER THAN USUAL. WHILE TROUBLESHOOTING, SHE PERFORMED NORMAL CONTROL TESTS AND RECEIVED RESULTS OF 190, 177, AND 184 MG/DL. THE NORMAL CONTROL RANGE IS 87-118 MG/DL. THE CONTACT DID NOT ALLEGE THE CUSTOMER EXPERIENCED ANY ADVERSE EVENTS. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION, AND REPLACEMENT STRIPS WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROFILL TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE LLC 7098 5LB3B08

    Patients

    Seq Age Sex Outcome Treatment
    1 YR