BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 5035792 · Received August 27, 2015

    Report

    Report Number
    1034569-2015-00123
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    July 31, 2015
    Report Date
    August 27, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE TEST WELL IMAGES ON THE ECHO. BATCH (B)(4) (RS3 R635 CRRIC 221440) SAMPLE (B)(4). CELL 1-NEGATIVE-VISUALLY APPERA TO HAVE SOME RED CELL ADHEARANCE AND WEAK POSITIVE. CELL 2-NEGATIVE-VISUALLY APPERA TO HAVE SOME RED CELL ADHEARANCE AND WEAK POSITIVE. CELL 3-NEGATIVE-VISUALLY NEGATIVE. CONTROL WELL (S) REACTED AS EXPECTED. BATCH (B)(4) (RS3 R635 CRRIC 221440) SAMPLE (B)(4) CELL 1-2+-VISUALLY APPEAR POSITIVE. CELL 2-2+-VISUALLY APPEAR POSITIVE. CELL 3-NEGATIVE-VISUALLY NEGATIVE. CONTROL WELL (S) REACTED AS EXPECTED. REPEAT OF SAMPLE FROM (B)(6) 2015. BATCH (B)(4) (RS3 R635 CRRIC 221440) SAMPLE (B)(4). CELL 1-1+-VISUALLY APPEAR POSITIVE. CELL 2-?-VISUALLY APPEAR WEAK POSITIVE. CELL 3-NEGATIVE-VISUALLY NEGATIVE. CONTROL WELL (S) REACTED AS EXPECTED. CUSTOMER WAS ADVISED THAT 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

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING A SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS3) ON THE GALILEO ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570465 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1