BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-E (MONOCLONAL BLEND) GAMMA-CLONE

    MDR report key: 5437153 · Received February 15, 2016

    Report

    Report Number
    1034569-2016-00027
    Event Type
    Malfunction
    Date Received
    February 15, 2016
    Date of Event
    January 1, 2012
    Report Date
    February 15, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    103640/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMMUCOR LABORATORY WAS UNABLE TO TEST RETENTION PRODUCT BECAUSE IT HAD ALREADY EXPIRED ON 12MAR2012, PRIOR TO THE REPORT OF THE EVENT FROM THE CUSTOMER SITE. A SEARCH OF THE DEVICE HISTORY RECORD FOR THIS PRODUCT WAS PERFORMED, AND DETERMINED THAT LOT NUMBER 964020 MET ALL OF THE PRODUCT REQUIREMENTS FOR POTENCY, REACTIVITY, AVIDITY AND SPECIFICITY PRIOR TO RELEASE. A REVIEW OF PRODUCT HISTORY REVEALED THAT THERE WERE NO ADDITIONAL COMPLAINTS OF UNEXPECTED NEGATIVE REACTIVITY THAT WERE RECEIVED FOR LOT NUMBER 964020. PRODUCT EXPIRED IN 2012.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WHEN USING GAMMA-CLONE ANTI-E (MONOCLONAL BLEND) WITH MANUAL TESTING METHODOLOGY, WHEN TESTED IN 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93976 ANTI-E (MONOCLONAL BLEND) GAMMA-CLONE BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 964020

    Patients

    Seq Age Sex Outcome Treatment
    1