BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-K (MONOCLONAL)

    MDR report key: 2562952 · Received May 8, 2012

    Report

    Report Number
    1034569-2012-00087
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    March 12, 2012
    Report Date
    May 8, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 103497
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT REAGENTS USED FOR INITIAL TESTING WERE OF THE SAME LOT BUT DIFFERENT VIALS OF REAGENTS THAN USED IN REPEAT TESTING. NO ADDITIONAL SAMPLE WAS AVAILABLE FOR TESTING. ON (B)(6) 2012, THE CUSTOMER STATED THAT SHE RE-TESTED THE DONOR SAMPLE WITH THE SAME LOT OF REAGENTS AND A DIFFERENT SEGMENT AND THE SAMPLE RESULTED AS NEGATIVE. THE CUSTOMER HAS NOT HAD ANY OTHER ISSUES WITH TESTING WITH ANY OTHER DONORS. A REVIEW OF THE MAINTENANCE, CAMERA REPORTS, AND EVENT LOG SHOWS THAT ALL MAINTENANCE WAS UP TO DATE ON THE DAYS OF TESTING. THE CAMERA REPORTS AND IMAGES SUGGEST THAT THE CAMERA WAS OPERATING AS EXPECTED. THE ERROR LOG SHOWED NO ERRORS ON THE DAY OF TESTING. QC AND ALL OTHER SAMPLES TESTED ON THE SAME DAY AND AROUND THE SAME TIME AS THE SAMPLE IN QUESTION REACTED AS EXPECTED. THIS SUGGESTS THAT THE REAGENTS AND INSTRUMENT WERE PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED INCONSISTENT REACTIONS WITH THE PHENOTYPING ASSAY ON THE ECHO WITH GAMMA-CLONE ANTI-K MONOCLONAL, LOT 924400.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-K (MONOCLONAL) BLOOD GROUPING REAGENT KSZ IMMUCOR, INC. 924400

    Patients

    Seq Age Sex Outcome Treatment
    1