BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (10)

    MDR report key: 1032078 · Received April 18, 2008

    Report

    Report Number
    1826988-2008-00451
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 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

    Additional Manufacturer Narrative · 1

    THE QA LAB RECEIVED USED TEST STRIPS, SO FURTHER EVAL WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE TESTED HER BLOOD GLUCOSE AND RECEIVED A READING OF 300 MG/DL USING HER CONTOUR METER. SHE RETESTED AND RECEIVED A READING OF 109 MG/DL USING ANOTHER METER. 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 A RESULT OF 385 MG/DL. THE NORMAL CONTROL RANGE WAS 97 -135 MG/DL. 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 (10) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 9507B 6GB3B73

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK