BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2498975 · Received March 21, 2012

    Report

    Report Number
    1034569-2012-00049
    Event Type
    Malfunction
    Date Received
    March 21, 2012
    Date of Event
    February 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF IMAGES: ORIGINAL SAMPLE WAS TESTED ON CRRS3 (LOT R195) AND RESULTED 2+ FOR CELL II. SAMPLE WAS TESTED BY CAPTURE-R READY ID (CRRID) (LOT ID154) AND CRRID EXTEND I (LOT DP053). AN ANTI-E WAS IDENTIFIED. FOR SAMPLE TESTED ON EXTEND I PANEL (DP053), CELLS 8, 9, 11, 12, 13, AND 14 WERE POSITIVE. CELL 10 (POSITIVE FOR E) WAS SCORED NEGATIVE BY ECHO, APPEARS VISUALLY POSITIVE). FOR SAMPLE TESTED ON CRRID (LOT ID154), CELLS 3 AND 14 WERE POSITIVE, VISUALLY POSITIVE. CELL 14 REACTED 4+ IS NEGATIVE FOR E ANTIGEN. CELL 6 (POSITIVE FOR E) WAS NEGATIVE, VISUALLY APPEARS NEGATIVE. ORIGINAL SAMPLE WAS RETESTED ON ECHO AND RESULTED NEGATIVE FOR ALL CELLS. A NEW SAMPLE DRAWN AFTER PLASMA TRANSFUSION WAS TESTED AND RESULTED NEGATIVE FOR ALL CELLS. VISUALLY CELL 2 APPEARS WEAKLY POSITIVE. VISUALLY APPEARS POSITIVE FOR CELL 2. SAMPLE WAS TESTED WITH CRRID EXTEND I (LOT DP053) AND CELLS 8, 9, 11, 12, 13, AND 14 WERE POSITIVE. CELL 10 (POSITIVE FOR E) WAS SCORED NEGATIVE BY ECHO, APPEARS VISUALLY POSITIVE). THE POSITIVE REACTION OF THE PRE-TRANSFUSION SAMPLE ON (B)(6) CELL 14 IS ATTRIBUTED TO ANTI-DIEGO (A) RED BLOOD CELL ANTIBODY WHICH HAS BEEN IDENTIFIED BY THE CUSTOMER. CUSTOMER STATES THEY HAVE CONFIRMED THE DIEGO ANTIBODY IN THIS PATIENT USING PANOCELL DI (A+) CELLS. CUSTOMERS WERE INSTRUCTED TO VISUALLY INSPECT NEGATIVE ECHO RESULTS WITH CAPTURE-R READY SCREEN AND CAPTURE-R READY ID IN TECHNICAL COMMUNICATION (B)(4) ON (B)(6) 2009. A SERVICE CALL WAS MADE. PERFORMED UNEXPECTED REACTION CHECKLIST AND FOUND TEST PERI-PUMP VOLUME TO BE 9.0G (EXPECTED VOLUME 9.9 TO 10.9 G). REPLACED PERIPUMP TUBING AND RE-RAN TEST PERI-PUMP. ICL., VOLUME WITHIN SPECS AT 10.1G. ALL OTHER PARAMETERS WITHIN SPECIFICATION. PERFORMED DAILY MAINTENANCE WITH ACCEPTABLE RESULTS. PERFORMED QC WITH ACCEPTABLE RESULTS. SYSTEM WAS TESTED AND IS OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULT WHEN TESTING A SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS 3) ON THE ECHO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1