BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 5345307 · Received January 5, 2016

    Report

    Report Number
    1034569-2016-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2016
    Date of Event
    December 8, 2015
    Report Date
    January 5, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 IN QUESTION: ECHO M01259- BATCH (B)(4) (R665, 221501). SCI- NEG RESULT- VISUALLY WEAKLY POSITIVE- SMALL CELL BUTTON AND RING OF ADHERENCE NOTED (JK(A)+,JK(B)-). SCII- NEG RESULT- VISUALLY NEGATIVE. SCIII- 3+ RESULT- VISUALLY POSITIVE (JK(A)+,JK(B)+). CONTROL WELL RESULTED AS EXPECTED . VISUALLY THE WELL THAT RESULTED AS NEGATIVE HAD A POSITIVE APPEARANCE. CUSTOMER 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN TESTING A PATIENT SAMPLE ON A GALILEO ECHO. THE PATIENT HAS A KNOWN ANTI-JKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4060 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR