BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1221913 · Received November 4, 2008

    Report

    Report Number
    1826988-2008-01323
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 16, 2008
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    A PHARMACIST CALLED ON BEHALF OF THE CUSTOMER. SHE STATED THAT THE CUSTOMER'S GLUCOSE WAS TESTED USING HIS CONTOUR METER, AND THE READING WAS 142 MG/DL. SHE SAID THE CUSTOMER WAS SYMPTOMATIC FOR LOW GLUCOSE SO HIS GLUCOSE WAS RETESTED USING ANOTHER METER. THE OTHER METER READ 18 AND 22 MG/DL. THE CUSTOMER WAS GIVEN JUICE TO RAISE HIS BLOOD GLUCOSE LEVELS. ON ANOTHER OCCASION, THE CUSTOMER'S CONTOUR READ 400 MG/DL, WHILE ANOTHER METER READ 40 MG/DL. THE DIFFERENCE BETWEEN BOTH SETS OF READINGS FALLS IN THE "D" ZONE OF THE PARKES ERROR GRID, MAKING THE DIFFERENCE CLINICALLY SIGNIFICANT. THE CUSTOMER'S TEST STRIPS ARE TO BE 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 7097B 7JC3C05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention