BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2382767 · Received December 20, 2011

    Report

    Report Number
    1034569-2011-00195
    Event Type
    Malfunction
    Date Received
    December 20, 2011
    Date of Event
    November 21, 2011
    Report Date
    December 20, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT IMAGES: BATCH 2014, CRRSC3 LOT R184, INDICATOR CELL LOT 221738: CELL1 1 VISUALLY NEGATIVE, CELL2 100 VISUALLY POSITIVE, CELL3 1 VISUALLY NEGATIVE. BATCH ID 2015, CRRID LOT ID148, INDICATOR CELL LOT 221738 CELLS 1-14 REACTED WITH REACTION STRENGTH OF 0. WHEN REVIEWING COLOR CHECK IMAGES, WELLS 1- 8 DO NOT APPEAR TO HAVE ADEQUATE SERUM DISPENSED IN WELLS. WELLS 9, 10, 12, 13, 14, 15 ARE DISPLAYING BUBBLES IN COLOR CHECK IMAGES. WELL 11 DOES NOT APPEAR TO HAVE PROPERLY DISPENSED SERUM IN WELL. TECHNICAL COMMUNICATION REGARDING LIQUID LEVEL DETECTION AND SAMPLE DISPENSE ON THE ECHO, (B)(4) INFORMED CUSTOMERS TO EVALUATE SAMPLE HANDLING PROCEDURES FOR GENERATION OF BUBBLES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULT WHEN TESTING A PATIENT SAMPLE ON WITH CAPTURE-R READY-ID (CRRID) LOT ID 148 ON THE ECHO INSTRUMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR