BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 1510356 · Received October 20, 2009

    Report

    Report Number
    1034569-2009-00363
    Event Type
    Malfunction
    Date Received
    October 20, 2009
    Date of Event
    September 21, 2009
    Report Date
    October 19, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK 070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT CAMERA IMAGES: CRRS LOT R057 (PATIENT HAS HISTORY OF ANTI-FYA) THE ECHO GENERATED NEGATIVE RESULTS FOR ALL CELLS. SCREEN CELLS 1 & 3 ARE FYA POSITIVE. CELL 2 IS FYA NEGATIVE. CELLS 1 & 3: WELL SCORE=1 VISUAL REVIEW OF IMAGE: SLIGHT DEGREE OF ADHERENCE/RED CELL BUTTON HAS A DIFFUSE BORDER. CRRID LOT ID119 CELLS 1,2,4,5,6,9,10 & 13 ARE FYA POSITIVE. THE ECHO GENERATED NEGATIVE RESULTS FOR ALL OF THESE CELLS. VISUAL REVIEW OF IMAGES (CELLS 1,2,4,5,6,9,10 & 13): SLIGHT DEGREE OF ADHERENCE. POSITIVE CONTROL=4+ WELL SCORE=100 NEGATIVE CONTROL=0 WELL SCORE=0 A SERVICE CALL WAS MADE. SYSTEM IS PERFORMING TO SPECIFICATIONS. THE REACTIVITY OF THE FYA ANTIGEN WAS CONFIRMED ON OUR RETENTION CRRS(3), LOT R057 AND RETENTION CRRID, LOT ID119. THE REACTIVITY OF THE FYA ANTIGEN WAS CONFIRMED ON RETURNED CRRS(3), LOT R057 WITH ANTI-FYA. NO ANTIGEN CONFIRMATION WAS PERFORMED ON THE RETURNED CRRID, LOT ID119 AS ONLY ONE STRIP WAS RECEIVED AND RESERVED FOR SAMPLE TESTING. THE SUBMITTED PLASMA SAMPLE (REPORTEDLY ANTI-FYA) WAS TESTED WITH RETURNED AND RETENTION CRRS (3), LOT R057 ON OUR IN-HOUSE ECHO. THE SAMPLE WAS NONREACTIVE WITH THE RETURNED LOT. THE SAMPLE WAS TESTED WITH RETENTION CRRID, LOT ID119. THE SAMPLE WAS NONREACTIVE WITH 1/3 FY(A+B-) CELLS, EQUIVOCAL, BUT VISUALLY POSITIVE WITH 1/3 FY(A+B-) CELLS, AND 3+ POSITIVE WITH 1/3 FY(A+B-) CELLS. THE SAMPLE REACTED EQUIVOCAL, BUT VISUALLY POSITIVE WITH 2/5 FY(A+B+) CELLS AND WAS NONREACTIVE WITH 3/5 FY(A+B+) CELLS. THE SAMPLE WAS TESTED WITH THE RETURNED CRRID, LOT ID119. THE SAMPLE REACTED 1+ WITH 1/3 FY(A+B-) CELLS AND EQUIVOCAL, BUT VISUALLY NEGATIVE WITH 1/5 FY(A+B+) CELLS. THE SAMPLE WAS NONREACTIVE WITH ALL OTHER FY(A+) CELLS. THE SAMPLE WAS TESTED WITH SELECTED FY(A+) AND FY(A-) RED CELLS FROM RETENTION PANOCELL-20. THE SAMPLE EXHIBITED 1+ REACTIVITY AND W+ TO 1+ REACTIVITY WITH THE FY(A+B-) AND FY(A+B+) RED CELLS, RESPECTIVELY, AT THE INDIRECT ANTIGLOBULIN TEST PHASE. THE EVENT APPEARS TO BE RELATED TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON SAMPLE FROM PATIENT WITH A HISTORY OF ANTI-FYA. THE ECHO GENERATED NEGATIVE RESULTS WHEN TESTING WITH CAPTURE-R READY SCREEN 3 (CRRS 3) AND CAPTURE-R READY ID (CRRID).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR