BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASCENSIA ELITE XL

    MDR report key: 1163670 · Received September 9, 2008

    Report

    Report Number
    1826988-2008-01016
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE TESTED HIS BLOOD GLUCOSE AND RECEIVED A READING OF 29 MG/DL USING HIS ELITE METER. HE RETESTED USING ANOTHER METER AND RECEIVED A READING OF 152 MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. NO ADVERSE EVENTS WERE ALLEGED. A CHECK STRIP AND CONTROL SOLUTION WERE SENT TO THE CUSTOMER FOR FURTHER TROUBLESHOOTING OF THE ELITE SYSTEM. NO PRODUCT WILL BE RETURNED AT THIS TIME.

    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