BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2291876 · Received October 13, 2011

    Report

    Report Number
    1034569-2011-00163
    Event Type
    Malfunction
    Date Received
    October 13, 2011
    Date of Event
    July 21, 2011
    Report Date
    October 12, 2011
    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

    REVIEW OF IMAGES: REVIEW OF BATCH (B)(4), CRRS3 LOT R162, CRRIC LOT 221688, SAMPLE ID (B)(6), SHOW THAT THE CUSTOMER RECEIVED A NEGATIVE INTERPRETATION ON ALL THREE CELLS. CELLS 2 AND 3 VISUALLY APPEAR TO HAVE SOME RED CELL ADHERENCE. THE POSITIVE CONTROL WELL APPEARED POSITIVE AS EXPECTED WITH A WELL SCORE OF A 4+ INTERPRETATION. CELLS 2 IS HETEROZYGOUS FOR JKA AND CELL 3 IS HOMOZYGOUS FOR JKA. THERE WAS ANOTHER SAMPLE ON THIS BATCH THAT RESULTED NEGATIVE AND VISUALLY APPEAR NEGATIVE ON THE ECHO. REVIEW OF BATCH (B)(4), CRRS3 LOT R162, CRRIC LOT 221688, SAMPLE ID (B)(6), SHOW THAT THE CUSTOMER RECEIVED A NEGATIVE INTERPRETATION ON CELLS ONE AND TWO. CELL 3 RESULTED WITH A 3+ REACTION THAT VISUALLY APPEAR POSITIVE. CELL 2 VISUALLY APPEAR TO HAVE SOME RED CELL ADHERENCE. THE POSITIVE CONTROL WELL APPEARED POSITIVE AS EXPECTED WITH A WELL SCORE OF A 4+ INTERPRETATION. CELLS 2 IS HETEROZYGOUS FOR JKA AND CELL 3 IS HOMOZYGOUS FOR JKA. THIS ISSUE WAS COMMUNICATED TO CUSTOMERS IN (B)(4) ON (B)(4) 2009, WHERE CUSTOMERS ARE ADVISED TO PERFORM A VISUAL VERIFICATION OF NEGATIVE REACTIONS BEFORE FINAL RELEASE OF THOSE WELL RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN UNEXPECTED NEGATIVE WHEN TESTING A SAMPLE ON THE ECHO. THE SAMPLE RESULTED NEGATIVE WITH CAPTURE-R READY SCREEN 3 (CRRS 3). A NEW SAMPLE WAS COLLECTED FROM THE SAME PATIENT LATER THE SAME DAY AND RESULTED POSITIVE FOR CELL 3 WITH CRRS3. THE SAMPLE WAS TESTED ON ECHO WITH CAPTURE-R READY ID CRRID AND THE SAMPLE RESULTED ANTI-JKA POSITIVE. CUSTOMER RE-TESTED THE ORIGINAL SAMPLE WHICH RESULTED 3+ WITH CRRS 3.

    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 61 YR