BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA DEX2

    MDR report key: 722403 · Received May 22, 2006

    Report

    Report Number
    1826988-2006-00578
    Event Type
    Malfunction
    Date Received
    May 22, 2006
    Date of Event
    May 10, 2006
    Report Date
    May 10, 2006
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE TROUBLESHOOTING, THE CUSTOMER RAN NORMAL CONTROL TESTS AND RECEIVED RESULTS OF 256 AND 239 MG/DL. THE NORMAL CONTROL RANGE IS 113-162 MG/DL. THE CUSTOMER DID NOT ALLEGE ANY ADVERSE EVENTS. THE METER AND STRIPS ARE TO BE RETURNED FOR EVAL, AND REPLACEMENT PRODUCTS WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA DEX2 BLOOD GLUCOSE METER NBW BAYER HEALTHCARE LLC A208298 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN