BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 5695725 · Received June 2, 2016

    Report

    Report Number
    1034569-2016-00121
    Event Type
    Malfunction
    Date Received
    June 2, 2016
    Date of Event
    May 5, 2016
    Report Date
    June 2, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001584
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE IMAGES FROM M01332: BATCH 22641 (R725 AND 221612) TESTED ON WEDNESDAY, MAY 4, 2016 11:47, SAMPLE W14795 KROHNE 753794, ALL 3 CELLS WERE NEGATIVE, CELL 2 WAS VISUALLY WEAKLY POSITIVE, CELL 2 IS E POSITIVE, CONTROLS WORKED AS EXPECTED. TECHNICAL COMMUNICATION CC 09-042-02 STATES THAT THE ECHO MAY GENERATE A NEGATIVE RESULT WITH CAPTURE-R PLATES, WHERE UPON SUBSEQUENT VISUAL INSPECTION THE CELL APPEARS WEAK POSITIVE OR EQUIVOCAL. CUSTOMER WAS ADVISED TO 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 UNEXPECTED NEGATIVE REACTIONS ON THE 3_CELL ASSAY ON THE GALILEO ECHO DURING CORRELATION STUDIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349232 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. 10888234001584

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR