BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA ELITE XL

    MDR report key: 1220767 · Received October 31, 2008

    Report

    Report Number
    1826988-2008-01285
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER TESTED HER BLOOD GLUCOSE USING HER 2 ELITE METERS AND RECEIVED READINGS OF 238 AND 275 MG/DL. SHE RETESTED USING HER CONTOUR METER AND RECEIVED A READING OF 74 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "D" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. CONTROL SOLUTION WAS SENT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING OF HER ELITE SYSTEMS. CUSTOMER SERVICE CONTACTED THE CUSTOMER A COUPLE OF WEEKS LATER. SHE STATED THAT EVERYTHING WAS WORKING PROPERLY AND SHE DECLINED TO RETURN ANY PRODUCT FOR EVALUATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA ELITE XL BLOOD GLUCOSE METER NBW BAYER HEALTHCARE, LLC 3901G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK