BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 5805516 · Received July 19, 2016

    Report

    Report Number
    1034569-2016-00170
    Event Type
    Malfunction
    Date Received
    July 19, 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-K), BATCH 13904 - R734 AND 221644; RESULTED AS NEGATIVE, CELL 1_NEG, CELL 2_NEG, CELL 3_NEG; CELL 1 IS VISUALLY 1+ POSITIIVE (K+). THE PI LAB CONFIRMED THE REACTIVITY OF THE K ANTIGEN ON CELL 1 OF RETENTION CAPTURE-R RS(3) LOT R734 IN MANUAL CAPTURE RETENTION CAPTURE-R INDICATOR CELL 221645 WITH RETENTION ANTI-K LOT DL8585A (1:1 DILUTION). CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 2+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED. CUSTOMER ADVISED THAT K+ CELL ON R734 WITH SAMPLE (B)(6) WAS VISUALLY POSITIVE, REFERRED TO (B)(4); WE ARE AWARE OF SOME INSTANCES ON THE ECHO WHERE THE INSTRUMENT MAY GENERATE A NEGATIVE WELL INTERPRETATION FOR CAPTURE-R READY-SCREEN OR CAPTURE-R READY-ID ASSAYS AND SUBSEQUENT VISUAL INTERPRETATION OF THOSE REACTIONS ARE WEAK POSITIVE OR QUESTIONABLE (EQUIVOCAL). WE ARE RECOMMENDING THAT YOU PERFORM A VISUAL VERIFICATION OF NEGATIVE REACTIONS BEFORE FINAL RELEASE OF THOSE WELL RESULTS.

    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)(4) IS HISTORICALLY ANTI-K POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458850 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. 10888234001584

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR