BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1111915 · Received August 8, 2008

    Report

    Report Number
    1826988-2008-00859
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    July 15, 2008
    Report Date
    July 15, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB FOUND THE RETURNED REAGENT TO READ E11 (CONFIRMS EXPOSURE) AND 79 MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    A PHARMACIST CALLED ON BEHALF OF THE CUSTOMER. SHE STATED THAT THE CUSTOMER RECEIVED AN E11 ERROR CODE WHEN TRYING TO TEST HER BLOOD GLUCOSE. THE INITIAL CALL DID NOT MEET THE CRITERIA TO BE REPORTED, BUT THE CUSTOMER'S TEST STRIPS WERE RETURNED FOR EVALUATION. 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 7098B 7JC3D07

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK