BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS

    MDR report key: 1960189 · Received December 15, 2010

    Report

    Report Number
    1826988-2010-00839
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 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
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB EVALUATED THE RETURNED REAGENT AND FOUND 1 OUT OF 5 CONTROL TESTS TO READ 41 MG/DL LOW, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED ABOUT AN ERROR CODE THAT HE RECEIVED WHEN TESTING WITH HIS CONTOUR METER. HIS INITIAL CALL DID NOT MEET THE CRITERIA TO BE REPORTED, BUT HIS 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 NBW BAYER HEALTHCARE, LLC 7080G 0BC3A05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK