BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 4437777 · Received January 21, 2015

    Report

    Report Number
    1034569-2015-00012
    Event Type
    Malfunction
    Date Received
    January 21, 2015
    Date of Event
    December 29, 2014
    Report Date
    January 21, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102116/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON (B)(6) 2015. THE RETENTION PRODUCT PERFORMED AS EXPECTED. THE IMMUCOR LABORATORY ALSO TESTED RETURNED BLOOD SAMPLE ON (B)(6) 2015 THAT WAS RECEIVED FROM THE CUSTOMER SITE. THIS RETURNED BLOOD SAMPLE YIELDED THE EXPECTED POSITIVE RESULT OUTCOME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN USING POLYCLONAL ANTI-FYB, WITH TUBE TESTING METHODOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49743 ANTI-FYB BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 613021

    Patients

    Seq Age Sex Outcome Treatment
    1