BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 1518412 · Received October 30, 2009

    Report

    Report Number
    1034569-2009-00378
    Event Type
    Malfunction
    Date Received
    October 30, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 29, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF CAMERA IMAGES:REAGENT POSITION-RX STRENGTH VISUAL INTERP ANTI A A8 - 93 STRONG AGGLUTINATION, CLEAR BACKGROUND; ANTI B B8 - 89 STRONG AGGLUTINATION, SLIGHT FUZZY BACKGROUND; ANTI D4 C8 - 89 STRONG AGGLUTINATION, SLIGHT FUZZY BACKGROUND; MONO CTL D8 - 25 VISUALLY NEGATIVE WELL.REFLEXFWD TESTING PERFORMED WITH IN-HOUSE DONOR SAMPLES OF KNOWN ABO/RH TYPES USING RETENTION ANTI-A, ANTI-B, LOT 203271, ANTI-D SERIES 4, ANTI-D SERIES 5 ON IN-HOUSE GALILEO. ALL IN-HOUSE DONOR SAMPLES TYPED AS EXPECTED. A SERVICE CALL WAS MADE. ADJUSTMENTS WERE MADE IN 14 LANE BAY AND AT PIPETTING STATIONS. CLEANED DEBRIS FROM CAMERA LENS AND TOOK NEW FLATFIELDS IMAGES. FWDABO ASSAY WAS PERFORMED ON 24 SAMPLES WITHOUT ERROR. INSTRUMENT IS WORKING WITHIN SPECIFICATIONS. REFLEXFWD TESTING PERFORMED WITH CUSTOMER'S DONOR SEGMENT (PREVIOUSLY TYPED AS GROUP A, D POSITIVE) USING RETENTION ANTI-A, ANTI-B, LOT 203271, ANTI-D SERIES 4, AND ANTI-D SERIES 5 ON IN-HOUSE GALILEO. SEGMENT SAMPLES WERE INTERPRETED BY IN-HOUSE GALILEO AS EXPECTED. PER THE OPERATOR'S MANUAL A LIMITATION EXISTS FOR FORWARD ABO TESTING. "FORWARD ONLY ABO-RH TESTING HAS A HIGHER RISK OF MISTYPE DUE TO THE ABSENCE OF REVERSE TYPE RESULTS. HAZARDOUS MISTYPES MAY OCCUR, SUCH AS AN A SAMPLE BEING INTERPRETED AS GROUP AB OR AN RH (D) NEGATIVE SAMPLE BEING INTERPRETED AS RH (D) POSITIVE. FOR THIS REASON ABO-RH RESULTS SHOULD ALWAYS BE COMPARED TO THE PATIENT OR DONOR HISTORY".

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ABO MISTYPE ON A SAMPLE TESTED ON THE GALILEO. THE DONOR SAMPLE TYPED AB POSITIVE ON THE INSTRUMENT, BUT TYPED A POSITIVE WHEN TESTED BY MANUAL TUBE METHOD. NO ADVERSE EVENT OCCURRED AS A RESULT OF THE MISTYPING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR