BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2658610 · Received July 17, 2012

    Report

    Report Number
    1034569-2012-00138
    Event Type
    Malfunction
    Date Received
    July 17, 2012
    Date of Event
    June 18, 2012
    Report Date
    July 17, 2012
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    FILE REVIEW SUMMARY: ON (B)(4) 2012. SAMPLE ID: (B)(6). ANTI-D: 2+ WELL SCORE=40, VISUAL REVIEW: RED CELL BUTTON HAS A FLARE, BATCH (B)(4), WEAK D 15:39. SAMPLE ID: (B)(6). ANTI-D: 2+ WELL SCORE=40, VISUAL REVIEW: RED CELL BUTTON HAS A FLARE, BATCH (B)(4), WEAK D QC PASSED 20:52. WBCORQC LEVEL 2: ANTI-D NEG WELL SCORE: 2 VISUAL REVIEW: RED CELL BUTTON HAS A FLARE. ON (B)(4) 2012 : BATCH (B)(4) 09:33, SAMPLE ID (B)(6). ANTI-D NEGATIVE WELL SCORE=2, VISUAL REVIEW: RED CELL BUTTON HAS A FLARE. A SERVICE CALL WAS MADE. THE PROBLEM WAS RESOLVED BY OPTIMIZATION OF THE CAMERA AND ROBOT SUBSYTEMS. THE INSTRUMENT WAS TESTED AND FOUND TO BE OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED UNEXPECTED POSITIVE RESULTS ON THE WEAK D ASSAY WHEN TESTING TWO PATIENT SAMPLES ON THE ECHO.

    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