BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO

    MDR report key: 2291879 · Received October 13, 2011

    Report

    Report Number
    1034569-2011-00157
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Date of Event
    September 14, 2011
    Report Date
    October 12, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK040013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT IMAGES: PLATE (B)(4), (B)(6) 2011 AT 2249 - ABORH ASSAY. SAMPLE (B)(6) (HISTORICAL APOS). WELL A12- NO ANTI-A DISPENSED INTO THE WELL. THIS SAMPLE RESULTED AS APOS. PLATE (B)(4), (B)(6) 2011 AT 2253- FWD ABO ASSAY- 10 SAMPLES. NO ANTI-A DISPENSED INTO ANY OF THE ROW A WELLS. PLATE RESULTED WITH ALL SAMPLES AS OPOS (EXCEPTION- A2 WAS NTD POS). THESE WERE OPOS SEGMENTS FROM DONOR UNITS. PLATE (B)(4), (B)(6) 2011 AT 2302 FWD ABO ASSAY- 10 SAMPLES. NO ANTI-A DISPENSED INTO ANY OF THE ROW A WELLS. PLATE RESULTED ALL SAMPLES AS BPOS. NOTE: WELL B10 HAS A BLUE COLOR . THESE WERE BPOS SEGMENTS FROM DONOR UNITS. PLATE (B)(4), (B)(6) 2011 AT 2308- FWD ABO ASSAY- 1 SAMPLE ON THIS RUN IN COLUMN 12. NO ANTI-A DISPENSED INTO THE A12 WELL. SAMPLE RESULTED AS INV POS DUE TO AN X PLACED IN WELL A12. A SERVICE CALL WAS MADE. REPLACED PIPETTOR DEBUBBLER TUBING. REPLACED ALL SYRINGES AND VALVES. 12 SAMPLES TESTED WITH EXPECTED RESULTS UNIT IS OPERATING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE GALILEO REPORTED RESULTS ON SAMPLES TESTED ON AN ABO PLATE AND 3 FWD ABO PLATES, BUT NO ANTI-A WAS WAS DISPENSED INTO THE ANTI-A WELLS ON ANY OF THOSE PLATES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1