BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD

    MDR report key: 3322264 · Received September 3, 2013

    Report

    Report Number
    1056600-2013-00052
    Event Type
    Malfunction
    Date Received
    September 3, 2013
    Date of Event
    August 7, 2013
    Report Date
    September 3, 2013
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETAINED TESTING, BATCH RECORD REVIEW, AND COMPLAINT BY LOT REVIEW WERE PERFORMED. SATISFACTORY RESULTS WERE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A POSITIVE ANTIBODY SCREEN (1+) WAS OBSERVED WITH A PATIENT SAMPLE WITH NO PRIOR HISTORY OF ANTIBODIES. AN ANTI-E WAS SUBSEQUENTLY IDENTIFIED (REACTION STRENGTH 1+). WHILE THE ANTIBODY PANEL WAS INCUBATING, CUSTOMER PERFORMED TWO CROSSMATCHES ON THE PROVUE WITH RED CELL DONOR UNITS CHOSEN AT RANDOM. COMPATIBLE RESULTS WERE OBSERVED. WHEN THE ANTI-E WAS IDENTIFIED, CUSTOMER ANTIGEN TYPED THE UNITS FOR THE E ANTIGEN USING TUBE METHOD. THE RESULTS WERE 3+ - 4+ POSITIVE WITH THE UNITS. CUSTOMER REPEATED THE CROSSMATCH TESTING ON THE BENCH USING THE SAME REAGENTS THAT WERE ON THE PROVUE AND THE RESULTS WERE ALSO NEGATIVE. ON (B)(6) 2013, THE PATIENT HAD RECEIVED ONE UNIT OF BLOOD. CUSTOMER STATED THAT ALL QC HAS PASSED, NO ISSUES REPORTED WITH THE GEL CARDS OR RED CELLS, AND THE PROVUE IS OPERATING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434795 ANTI-HUMAN GLOBULIN ANTI-IGG (RABBIT) MTS ANTI-IGG CARD ANTIBODY SCREENING REAGENT KSZ MICROTYPING SYSTEMS 042313001-08

    Patients

    Seq Age Sex Outcome Treatment
    1