BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 1843509 · Received September 24, 2010

    Report

    Report Number
    1034569-2010-00207
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 27, 2010
    Report Date
    September 23, 2010
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK 070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL REVIEW OF IMAGES INDICATED THE APPEARANCE OF A RING IN THE CENTER OF THE WELL. THE CUSTOMER WAS INFORMED THAT A SHAKE GAP OPTIMIZATION IS REQUIRED. A SERVICE CALL WAS MADE. OPTIMIZED SHAKE GAP IN SOFTWARE. PERFORMED GROUP/SCREEN QC ASSAY WITH ACCEPTABLE RESULTS. TESTED 2 PATIENT SAMPLES USING GROUP/SCREEN ASSAY WITH ACCEPTABLE RESULTS. TESTED 2 SAMPLES FROM THE PATIENT WITH ACCEPTABLE RESULTS (PATIENT RESULTS = A NEG) THE SYSTEM WAS TESTED AND PERFORMED WITHIN SPECIFICATIONS WITH NO PROBLEMS OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RH DISCREPANCY ON THE ECHO. THE PATIENT SAMPLE RESULTED AS A POSITIVE. A NEW SAMPLE WAS COLLECTED FROM THE SAME PATIENT AND ABO CONFIRMATION TESTING WAS PERFORMED BY TUBE METHOD, RESULTING AS A NEG. WEAK D TESTING PERFORMED BY TUBE METHOD WAS NEGATIVE. THE INITIAL SAMPLE WAS RE-TESTED ON THE ECHO AND REPORTED AS NTD. THE NEW SAMPLE WAS TESTED ON THE ECHO WITH RESULT OF A NEG.

    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 55 YR