BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASCENSIA DEX2 (US)

    MDR report key: 643548 · Received October 27, 2005

    Report

    Report Number
    1826988-2005-00043
    Event Type
    Other
    Date Received
    October 27, 2005
    Date of Event
    October 14, 2005
    Report Date
    October 14, 2005
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER CALLED STATING THAT HIS METER WAS REPORTING FALSE RESULTS. HE RECEIVED A RESULT OF 497 MG/DL ON HIS METER AND A RESULT OF 180 MG/DL ON ANOTHER METER. AN EVALUATION OF THE METER WAS CONDUCTED OVER THE PHONE, WHICH DETERMINED THAT THE METER WAS WORKING WITHIN SPECIFICATIONS. CUSTOMER ASKED TO RETURN METER FOR FURTHER EVALUATION AND A REPLACEMENT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA DEX2 (US) BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 3952M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other