BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 4337542 · Received December 17, 2014

    Report

    Report Number
    1034569-2014-00229
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    November 18, 2014
    Report Date
    December 16, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELL IMAGES. BATCH 38434 TESTED ON 17NOV2014 USING LOTS ID230, 221264 NEGATIVE REACTIONS FOR ALL CELLS. ALL CELLS EXCEPT 1, 3, AND 6 ARE E=, THESE E= CELLS ARE ALL VISUALLY NEGATIVE. CELLS 1 (E+E+), 3 (E+E=), AND 6 (E+E+) ARE VISUALLY EQUIVOCAL ALTHOUGH RESULTED NEGATIVE BY THE ECHO. CONTROLS REACTED AS EXPECTED AN IMMUCOR FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE TO ASSESS THE INSTRUMENT. ALL MAINTENANCE IS UP TO DATE AND ACCEPTABLE, ALL OTHER SAMPLES AND QC ARE REACTING AS EXPECTED INDICATING INSTRUMENT AND REAGENTS ARE ACCEPTABLE. THIS SAMPLE WAS W+ IN TUBE WITH PEG. ALTHOUGH RESULTED NEGATIVE BY THE ECHO THERE IS REACTIVITY IN THE E= CELLS. THE ECHO RESULTED NEGATIVE BUT THERE WAS VISUAL REACTIVITY IN THE WELLS. CUSTOMER COMMUNICATION CC 09-042-02, RELEASED IN NOVEMBER 2009, ADVISED CUSTOMERS TO PERFORM A VISUAL VERIFICATION OF NEGATIVE CAPTURE-R SCREEN AND ID REACTIONS ON THE ECHO.

    Description of Event or Problem · 1

    ON (B)(6) 2014, IMMUCOR RECEIVED A COMPLAINT FOR UNEXPECTED NEGATIVE RESULTS WHEN TESTING A BLOOD SAMPLE USING CAPTURE-R READY-ID (CRRID) ON THE GALILEO ECHO INSTRUMENT, WHEN TESTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827117 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR