BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN 3

    MDR report key: 1598601 · Received February 12, 2010

    Report

    Report Number
    1034569-2010-00042
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 19, 2010
    Report Date
    February 12, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULTS FILES SHOWS WELL SCORES OF 2, 0, & 1 FOR CELLS I. II & III OF CRRS(3), LOT R070 RESPECTIVELY. WELL IMAGES LOOK NEGATIVE. ALL CELLS SHOULD HAVE RESULTED POSITIVE. CELL I IS A HOMOZYGOUS JKB CELL. CELLS II & III ARE HOMOZYGOUS FYB CELLS. THE REACTIVITY OF THE FYB AND JKB ANTIGENS WAS CONFIRMED ON RETENTION CRR(3), LOT R070 WITH ANTI-FYB, LOT FYB60H-1 AND ANTI-JKB, LOT RPS3921105. THE REACTIVITY OF THE FYB AND JKB ANTIGENS WAS CONFIRMED ON RETURNED CRR(3), LOT R070 WITH ANTI-FYB, LOT FYB60H-1 AND ANTI-JKB, LOT RPS3921105. THE SUBMITTED SAMPLE (REPORTED TO HAVE ANTI-FYB, -JKB AND ANTI-KNOPS) WERE TESTED WITH RETURNED AND RETENTION CRRS(3), LOT R070 ON IN-HOUSE ECHO AND IN MANUAL CAPTURE. THE SAMPLE WAS NONREACTIVE WITH ALL CELLS TESTED. THE SAMPLE WAS TESTED USING SELECTED FY(A-B+), JK(A-B+) AND FY (A+B-),JK(A+B-), KN(A+) CELLS FROM RETENTION PANOCELL-20, LOT 02943. TWO SETS OF TESTING PARAMETERS WERE PERFORMED; A- IMMEDIATE SPIN (IS) AND 15' ROOM TEMPERATURE (RT) AND B- 15'37C TO ANTIGLOBULIN TEST (IAT). THE SAMPLE EXHIBITED +W TO 1+ REACTIVITY AT IS AND RT WITH FY(A-B+), JK(A-B+) AND WAS NONREACTIVE WITH FY (A+B+-), JK(A+B-) ,KN(A+). THE SAMPLE WAS NONREACTIVE AT 37C AND AT IAT. IT APPEARS THAT THE SAMPLE'S ANTIBODY IS PREDOMINANTLY IGM. CAPTURE ASSAYS ARE DESIGNED TO DETECT IGG ANTIBODIES TO RED BLOOD CELL ANTIGENS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS 3) ON THE ECHO. NO ADVERSE REACTIONS OCCURRED AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR R070

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR