BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1854362 · Received September 29, 2010

    Report

    Report Number
    1826988-2010-00675
    Event Type
    Malfunction
    Date Received
    September 29, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    PMA / PMN Number
    K062058
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB FOUND THE RETURNED REAGENT TO READ E11 (CONFIRMS EXPOSURE) AND 356 MG/DL HIGH, OUT OF SPECIFICATION. THE EXPOSURE WAS MOST LIKELY THE CAUSE OF THE HIGH RESULT. RESULTS WERE SATISFACTORY USING (B)(4) RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT SHE RECEIVED AN E11 ERROR CODE WHEN TESTING HER BLOOD GLUCOSE. NO ADVERSE EVENTS WERE ALLEGED. THE CUSTOMER'S INITIAL COMPLAINT DID NOT MEET THE CRITERIA TO BE REPORTED, BUT HER 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 NBW BAYER HEALTHCARE, LLC 7098B 9GC3A03

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK