BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1031882 · Received April 15, 2008

    Report

    Report Number
    1826988-2008-00387
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB FOUND THE RETURNED REAGENT TO READ AN AVERAGE OF 71MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE RECEIVED SOME HIGH RESULTS WITH HIS CONTOUR METER. HIS INITIAL CALL DID NOT MEET THE CRITERIA TO BE REPORTED. NO ADVERSE EVENT WERE ALLEGED. 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 7KC3C01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK