BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1209828 · Received October 15, 2008

    Report

    Report Number
    1826988-2008-01178
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 15, 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 THAT RETURNED REAGENT TO READ AN AVERAGE OF 232 MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READINGS HAD BEEN HIGHER THAN USUAL WHEN USING HER CONTOUR METER. HER INITIAL COMPLAINT DID NOT MEET THE CRITERIA TO BE REPORTED, BUT HER 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 7080D 7FC3D16

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK