BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 1052395 · Received May 23, 2008

    Report

    Report Number
    1826988-2008-00539
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 25, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE REC'D 8 NEW CARTONS OF TEST STRIPS FROM HIS SUPPLIER. WHEN HE OPENED THE CARTONS, HE FOUND CAPS OPEN ON 2 OF THE BOTTLES. NO ADVERSE EVENTS WERE ALLEGED. THE TEST STRIPS WERE RETURNED FOR EVAL, AS EXPOSURE TO MOISTURE CAN CAUSE HIGH TEST RESULTS. 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 CLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7KC3A04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK