BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 5808472 · Received July 20, 2016

    Report

    Report Number
    1034569-2016-00168
    Event Type
    Malfunction
    Date Received
    July 20, 2016
    Date of Event
    June 23, 2016
    Report Date
    July 19, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001584
    PMA / PMN Number
    BK070016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC ACCESS METHOD TO ASSESS THE TESTING WELL IMAGES IN QUESTION: SAMPLE (B)(6)(ANTI-FY(A) BATCH 19347 - R734 AND 221644; RESULTED AS NEGATIVE. CELL 1_NEG, CELL 2_NEG, CELL 3_NEG; CELL 3 HAD A SCORE OF 2. THE PI LAB CONFIRMED THE REACTIVITY OF THE FY(A) ANTIGEN ON CELL 3 OF RETENTION CAPTURE-R RS(3) LOT R734 IN MANUAL CAPTURE RETENTION CAPTURE-R INDICATOR CELL 221645 WITH RETENTION ANTI-FY(A) LOT DL7866A (1:1 DILUTION). CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 3+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. PERFORMED AN ANTIBODY SCREEN ON THE ECHO WITH CUSTOMER'S RETURNED SAMPLES (B)(6) USING RETENTION CAPTURE-R READY SCREEN (3), PLATES LOT R734 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221656. CONTROLS PERFORMED AS EXPECTED. RETURN SAMPLE (B)(6) EXHIBITED 4+ REACTIVITY WITH CELL 3 (FYA+FYB=). RETURN SAMPLE (B)(6) EXHIBITED 3+ REACTIVITY WITH CELL 3 (FYA+FYB=). CUSTOMER'S ISSUE WAS NOT REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE RESULT WITH CAPTURE-R READY-SCREEN 3 (CRRS 3) WHEN TESTING A PATIENT SAMPLE ON THE GALILEO ECHO. SAMPLE (B)(6) CONTAINED AN ANTI-FY(A) WHICH WAS IDENTIFIED USING CAPTURE-R READY-ID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463701 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. 10888234001584

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR