BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1212751 · Received October 20, 2008

    Report

    Report Number
    1826988-2008-01199
    Event Type
    Malfunction
    Date Received
    October 20, 2008
    Date of Event
    September 29, 2008
    Report Date
    September 29, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB FOUND THE RETURNED REAGENT TO READ E11 (CONFIRMS EXPOSURE) AND AN AVERAGE OF 77 MG/DL HIGH, OUT OF SPECIFICATION. PERFORMANCE WAS SATISFACTORY USING IQA RETENTION REAGENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE RECEIVED CONTROL TEST RESULTS THAT WERE HIGH, OUT OF SPECIFICATION. HIS INITIAL COMPLAINT DID NOT MEET CRITERIA TO BE REPORTED, BUT HIS 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 (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 9507B 7KC3C51

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK