BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1052392 · Received May 23, 2008

    Report

    Report Number
    1826988-2008-00542
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 26, 2008
    Report Date
    April 26, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINT OF LOW READINGS WAS NOT CONFIRMED BY THE QA LAB. THE LAB DID, HOWEVER, FIND THE TEST STRIPS TO READ E11 (CONFIRMS EXPOSURE) AND AN AVERAGE OF 14 MG/DL HIGH, OUT OF SPEC. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE USING HER CONTOUR METER AND REC'D READINGS OF 10, 42, 71, AND 12 MG/DL. SHE RETESTED USING ANOTHER METER AND REC'D A READING OF 179 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. THE TEST STRIPS WERE RETURNED FOR EVAL. REPLACEMENT TEST STRIPS WERE SENT TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7JC3C06

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK