BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 863773 · Received June 6, 2007

    Report

    Report Number
    1826988-2007-00292
    Event Type
    Malfunction
    Date Received
    June 6, 2007
    Date of Event
    May 25, 2007
    Report Date
    May 25, 2007
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB FOUND ONE RETURNED BOTTLE OF REAGENT TO READ AN AVERAGE OF 41 MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE HAD RECEIVED SOME CONTROL TEST RESULTS THAT WERE OUT OF RANGE. HE DID NOT ALLEGE ANY ADVERSE EVENTS. THE TEST STRIPS WERE RETURNED FOR EVALUATION, AND 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 7080D 6DB3A04

    Patients

    Seq Age Sex Outcome Treatment
    1 YR