BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHO

    MDR report key: 1462596 · Received September 4, 2009

    Report

    Report Number
    1034569-2009-00292
    Event Type
    Malfunction
    Date Received
    September 4, 2009
    Date of Event
    August 5, 2009
    Report Date
    September 1, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK 070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT IMAGES FOR TESTING WITH CRRS 3 SHOWS: EQUIVOCAL REACTION WITH CELL I (HOMOZYGOUS FOR FYA), NEGATIVE REACTION WITH CELL II (HOMOZYGOUS FOR FYA), AND NEGATIVE REACTION WITH CELL III (NEGATIVE FOR FYA). A SERVICE CALL WAS MADE AND THE CAMERA READER WAS REPLACED. THE PATIENT SAMPLE WAS RETESTED AND CONTINUED TO SHOW NEGATIVE RESULTS. THE REACTIVITY OF THE FYA ANTIGEN WAS CONFIRMED ON RETENTION CRRS(3) LOT R 054 AND CRRID EXTEND LOT DP 036. THESE LOTS WERE USED BY THE CUSTOMER AT THE TIME OF THE EVENT. THE RETURNED PATIENT SAMPLE WAS TESTED WITH RETENTION CRRS(3) ON AN IN-HOUSE ECHO. THE ECHO RESULTED IN A POSITIVE ANTIBODY SCREEN INTERPRETATION. THE SAMPLE, REPORTED TO HAVE ANTI-FYA, REACTED 3+ WITH CELL 1, FY(A+B-) AND NEGATIVE WITH CELL II, FY(A+B-). THE SAMPLE WAS TESTED WITH RETENTION CRRID ON AN IN-HOUSE ECHO. THE SAMPLE REACTED EQUIVOCAL, WITH 7 OF 9 FY(A+) RED CELLS AND WAS NONREACTIVE WITH 2 OF 9 FY(A+) RED CELLS. THE SAMPLE WAS TESTED BY TUBE HEMAGGLUTINATION TESTS WITH SELECTED FY(A+B+), FY(A+B-) AND FY(A-B+) REAGENT FROM RETENTION PANOCELL-10. A ROOM TEMPERATURE INCUBATION WAS INCLUDED. THE SAMPLE EXHIBITED WEAK REACTIVITY AT THE INDIRECT ANTIGLOBULIN TEST WITH THE FY(A+) REAGENT RED CELLS. THE EVENT APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON THE ECHO FOR ANTIBODY SCREEN WITH CAPTURE-R READY-SCREEN 3 (CRRS 3). CUSTOMER STATED THAT THE PATIENT SAMPLE HAD AN ANTI-FYA. NO TRANSFUSION REACTIONS WERE REPORTED AS A RESULT OF THIS NEGATIVE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR