BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 2770315 · Received October 3, 2012

    Report

    Report Number
    1034569-2012-00181
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 10, 2012
    Report Date
    October 3, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE IMAGE RESULT REVIEW OF THE EVENT LOG, NO ERRORS WERE NOTED PRIOR TO, DURING, OR AFTER THE UNEXPECTED NEGATIVE RESULTS WERE OBTAINED. REVIEW OF THE INITIAL SCREEN SHOWED THAT THE ECHO INTERPRETED CELL 1 AS POSITIVE AND CELLS 2 AND 3 AS NEGATIVE. THE VISUAL REVIEW AGREED WITH THE ECHO INTERPRETATION. REVIEW OF THE ANTIBODY IDENTIFICATION ASSAY SHOWED THAT THE VISUAL REVIEW AGREED WITH THE ECHO INTERPRETATION OF ALL 14 CELLS. ANTI-JKA WAS IDENTIFIED AND SHOWING DOSAGE. ALL HOMOZYGOUS CELLS WERE POSITIVE. THE CUSTOMER WAS ASKED TO PERFORM TESTING WITH A DIFFERENT LOT OF 3_CELL PLATES AND ALL JKA POSITIVE CELLS WERE NEGATIVE. THE CUSTOMER WAS INFORMED OF LIMITATION # 13 IN THE PACKAGE INSERT WHICH STATES, "THE GENETIC BACKGROUND OF DONORS OF REAGENT RED CELLS WITH PHENOTYPES SUCH AS FY (A+B-), FY (A-B+), JK (A+B-), JK (A-B+), M+N-, M-N+, S+S- OR S-S+ IS NOT KNOWN. SUCH RED BLOOD CELLS ARE ASSUMED TO BE FROM GENETIC HOMOZYGOTES, BUT IN FACT, COULD HAVE BEEN COLLECTED FROM PERSONS WHO ARE GENETICALLY HETEROZYGOUS FOR THE ENCODING GENES. NO SEROLOGICAL TESTS HAVE BEEN PERFORMED TO DEMONSTRATE THE RED BLOOD CELLS OF APPARENT HOMOZYGOTES USED TO PREPARE CAPTURE-R READY-SCREEN OR CAPTURE-R READY-ID CARRY A DOUBLE DOSE OF THE APPROPRIATE ANTIGENS". CONFIRMED THE PRESENCE OF THE JKA ANTIGEN ON RETENTION AND RETURNED CRRS(3), LOT R234 AND R245. PERFORMED SCREENED ASSAY ON THE ECHO WITH SAMPLE ID (B)(4) ON THE ECHO WITH RETURNED AND RETENTION CRRS(3), LOT R234 AND R245. THE RESULTS WERE AS FOLLOWS: SCREENING WELLS 1, 2, 3, 4, R234-RETURNED: 4+, 1+, 2+, 4+, R234-RETENTION: 4+, 0, 0, 4+, R245-RETURNED: 3+, 4+, 4+, ?= EQUIVOCAL, VISUAL POS. R245-RETENTION: 4+, 4+, 4+, REPEATED, SAME RESULTS. THE SAMPLE WAS TESTED WITH CRRID EXTEND I, LOT DP058. THE SAMPLE (B)(4) REACTIVITY WITH JK(A-) REAGENT RED CELLS RANGE FROM - TO 3+ REACTIVITY. CELL 4, JK(A+B-) GAVE NEGATIVE REACTIVITY, THE SAME AS THE JK(A+B-) CELL 3 OF RETENTION R234. THE SAMPLE WAS DEPLETED FOR FURTHER INVESTIGATION. THE CUSTOMER'S NEGATIVE RESULTS WAS REPRODUCED ON RETENTION R234 ONLY. THE 4+ REACTIVITY OF CELL 1, JK(A-) RED CELLS WAS CONSISTENT WITH BOTH THE RETURNED AND RETENTION R234. THE UNEXPLAINED REACTIVITY WITH JK(A-) IS SAMPLE RELATED. WE SUGGEST THAT SAMPLE SHOULD BE REFERRED TO AND IMMUNLHEMATOLOGY REFERENCE LABORATORY FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIONS WERE OBTAINED WITH CAPTURE-R READY-SCREEN (3) TEST WELLS ON THE ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R234

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR