BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-FYB

    MDR report key: 6940902 · Received October 11, 2017

    Report

    Report Number
    1034569-2017-00274
    Event Type
    Malfunction
    Date Received
    October 11, 2017
    Date of Event
    August 9, 2017
    Report Date
    October 11, 2017
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234000808
    PMA / PMN Number
    102116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR LABORATORY TESTED RETENTION PRODUCT ON 10AUG2017 WHICH PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS DETERMINED THAT A CUSTOMER REPORT FROM (B)(6) 2017 OF AN UNEXPECTED POSITIVE RESULT WHEN USING ANTI-FYB BY MANUAL TEST TUBE METHOD, WAS REPORTABLE. THE TESTING HAPPENED ON (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719150 ANTI-FYB BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 613030 10888234000808

    Patients

    Seq Age Sex Outcome Treatment
    1