BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELITE TEST STRIPS (50)

    MDR report key: 1001144 · Received February 15, 2008

    Report

    Report Number
    1826988-2008-00187
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 29, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE TESTED HIS BLOOD GLUCOSE USING HIS ELITE METER AND RECEIVED A READING OF 400 MG/DL. HE TESTED USING ANOTHER METER AND RECEIVED A READING OF 120MG/DL. THE DIFFERENCE BETWEEN THE READINGS FALLS IN THE "C" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. WHILE TROUBLESHOOTING, THE CUSTOMER PERFORMED CONTROL TESTS AND RECEIVED RESULTS OF 213 AND 219 MG/DL. THE NORMAL CONTROL RANGE WAS NOT PROVIDED, BUT SHOULD BE AROUND 70-100 MG/DL. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS ARE TO BE RETURNED FOR EVALUATION. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC NOT PROVIDED 7C05BS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK