BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 1904694 · Received November 22, 2010

    Report

    Report Number
    1034569-2010-00243
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 18, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK 070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF 3 CELL SCREEN RESULTS: CUSTOMER RECEIVED A 3+ REACTION FOR CELL 1, NEGATIVE FOR CELL 2, AND 2+ FOR CELL 3. ALL CELLS VISUALLY APPEAR POSITIVE. CRRID RESULTS: 3+ WITH CELL 1, 2+ WITH CELL 2, AND 3+ WITH CELL 3. ALL CELLS VISUALLY APPEAR POSITIVE. THE POSITIVE CONTROL WELL APPEARED POSITIVE AS EXPECTED. 3 CELL SCREEN: 2+ REACTION ON CELL 1 AND EQUIVOCAL ON CELL 2. CELL 3 RESULTED NEGATIVE, BUT ALL THREE CELLS VISUALLY APPEAR POSITIVE. THE POSITIVE CONTROL WELL APPEARED POSITIVE AS EXPECTED WITH A WELL SCORE OF A 4+ INTERPRETATION. CRRID: 2+ REACTION FOR CELLS 9, FOR CELLS 10,12, AND 13, 1+ FOR CELLS 11 AND 14. OTHER CELLS RESULTED NEGATIVE. VISUALLY ALL THE CELLS APPEAR VISUALLY POSITIVE. THE POSITIVE AND NEGATIVE CONTROL WELL APPEAR AS EXPECTED WITH WELL SCORE OF 4+ FOR POSITIVE CONTROL AND 0 FOR NEGATIVE CONTROL. CRRID: 2+ REACTION FOR CELLS 2, 5,12,AND 13. ? FOR CELLS 6 AND 7. THEY RECEIVED 3+ FOR CELLS 1, 3, 4, 8, 9-11 AND 14. OTHER CELLS RESULTED NEGATIVE. VISUALLY ALL THE CELLS APPEAR VISUALLY POSITIVE. THE POSITIVE AND NEGATIVE CONTROL WELL APPEAR AS EXPECTED WITH WELL SCORE OF 4+ FOR POSITIVE CONTROL AND 0 FOR NEGATIVE CONTROL. CUSTOMERS WERE NOTIFIED OF THIS ISSUE IN TECHNICAL COMMUNICATION (B)(4) ON (B)(6) 2009. CANNOT RULE OUT NATURE OF THE SAMPLE AS THE CAUSE OF THE UNEXPECTED RESULTS AS NEGATIVE RESULTS WERE OBTAINED BY MANUAL TUBE METHOD AND MANUAL CRRID.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PATIENT SAMPLES RESULTED NEGATIVE ON THE ECHO BUT VISUALLY APPEAR POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR

    Patients

    Seq Age Sex Outcome Treatment
    1