BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR TEST STRIPS (50)

    MDR report key: 991694 · Received January 29, 2008

    Report

    Report Number
    1826988-2008-00149
    Event Type
    Malfunction
    Date Received
    January 29, 2008
    Date of Event
    January 18, 2008
    Report Date
    January 18, 2008
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE QA LAB RECEIVED 2 TEST STRIPS. ONE TEST STRIP READ 59 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. SHE DID NOT ALLEGE ANY ADVERSE EVENTS. HER TEST STRIPS WERE RETURNED FOR EVALUATION, AND SHE RECEIVED REPLACEMENT TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR TEST STRIPS (50) BLOOD GLUCOSE TEST STRIPS NBW BAYER HEALTHCARE, LLC 7080A 6FB3C09

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK