BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 2222125 · Received August 24, 2011

    Report

    Report Number
    1034569-2011-00120
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 23, 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 RESULTS:CROSSMATCH ASSAY: FOUR DONOR UNITS (C POSITIVE) TESTED WITH PATIENT SAMPLE (B)(4) (CONTAINING ANTI-C).(B)(4) RESULTED COMPATIBLE WITH A VERY FUZZY BUTTON, VISUALLY THE REACTION APPEARED NEGATIVE. THE CONTROL WELL REACTED 3+ POSITIVE. (B)(4) RESULTED COMPATIBLE WITH A VERY FUZZY BUTTON, VISUALLY THE REACTION APPEARED NEGATIVE. THE CONTROL WELL REACTED 3+ POSITIVE. (B)(4) RESULTED COMPATIBLE WITH A VERY FUZZY BUTTON, VISUALLY THE REACTION APPEARED NEGATIVE. THE CONTROL WELL REACTED 3+ POSITIVE. (B)(4) RESULTED COMPATIBLE WITH A VERY FUZZY BUTTON, VISUALLY THE REACTION APPEARED NEGATIVE. THE CONTROL WELL REACTED 3+ POSITIVE. THE PATIENT SAMPLE WAS TESTED WITH CAPTURE-READY SCREEN 3 AND RESULTED POSITIVE.REVIEW OF IMAGES FOR TESTING WITH CAPTURE-R READY ID (CRRID):SAMPLE ID NUMBER: (B)(4), INSTRUMENT SERIAL NUMBER: (B)(4), LOT NUMBERS: ID144, (B)(4).CELL 1 REACTION AND ZYGOSITY (IF APPLICABLE): NEGATIVE, C NEGATIVEVISUALLY THIS CELL APPEARED: NEGATIVE.CELL 2 REACTION AND ZYGOSITY (IF APPLICABLE): NEGATIVE, C NEGATIVEVISUALLY THIS CELL APPEARED: NEGATIVE.CELL 3 REACTION AND ZYGOSITY (IF APPLICABLE): 3+ POSITIVE, HOMOZYGOUS FOR CVISUALLY THIS CELL APPEARED: POSITIVE.CELL 4 REACTION AND ZYGOSITY (IF APPLICABLE): EQUIVOCAL, HOMOZYGOUS FOR CVISUALLY THIS CELL APPEARED: WEAK POSITIVE.CELL 5 REACTION AND ZYGOSITY (IF APPLICABLE): NEGATIVE, HETEROZYGOUS FOR CVISUALLY THIS CELL APPEARED: NEGATIVE.CELL 6 REACTION AND ZYGOSITY (IF APPLICABLE): 3+ POSITIVE, HOMOZYGOUS FOR CVISUALLY THIS CELL APPEARED: POSITIVE.CELL 7 REACTION AND ZYGOSITY (IF APPLICABLE): NEGATIVE, HETEROZYGOUS FOR C VISUALLY THIS CELL APPEARED: NEGATIVE.CELL 8 REACTION AND ZYGOSITY (IF APPLICABLE): 3+ POSITIVE, HOMOZYGOUS FOR CVISUALLY THIS CELL APPEARED: POSITIVE.CELL 9 REACTION AND ZYGOSITY (IF APPLICABLE): 3+ POSITIVE, HOMOZYGOUS FOR CVISUALLY THIS CELL APPEARED: POSITIVE.CELL 10 REACTION AND ZYGOSITY (IF APPLICABLE): 3+ POSITIVE, HOMOZYGOUS FOR CVISUALLY THIS CELL APPEARED: POSITIVE.CELL 11 REACTION AND ZYGOSITY (IF APPLICABLE): 3+ POSITIVE, HOMOZYGOUS FOR CVISUALLY THIS CELL APPEARED: POSITIVE.CELL 12 REACTION AND ZYGOSITY (IF APPLICABLE): 3+ POSITIVE, HOMOZYGOUS FOR CVISUALLY THIS CELL APPEARED: POSITIVE.CELL 13 REACTION AND ZYGOSITY (IF APPLICABLE): 3+ POSITIVE, HOMOZYGOUS FOR CVISUALLY THIS CELL APPEARED: POSITIVECELL 14 REACTION AND ZYGOSITY (IF APPLICABLE): NEGATIVE, NEGATIVE FOR CVISUALLY THIS CELL APPEARED: NEGATIVE.POSITIVE CONTROL WELL REACTION: 4+ POSITIVEVISUALLY THIS WELL APPEARED: POSITIVE.NEGATIVE CONTROL WELL REACTION: NEGATIVEVISUALLY THIS WELL APPEARED: NEGATIVE.THE SAMPLE IS SHOWING DOSAGE AND IS NOT REACTING WITH HETEROZYGOUS C POSITIVE CELLS. THE DONORS UNITS WERE NOT TYPED FOR THE C ANTIGEN TO DETERMINE ZYGOSITY. CUSTOMER DOES NOT HAVE PATIENT OR DONOR SAMPLE TO REPEAT TESTING. THE SAMPLE CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    CUSTOMER STATES THEY ARE GETTING UNEXPECTED NEGATIVE REACTIONS (COMPATIBLE) WHEN PERFORMING CROSSMATCH ASSAY ON THE ECHO. THE PATIENT SAMPLE CONTAINS AN ANTI-C. THEY CROSSMATCHED 8 ABO COMPATIBLE RANDOM UNITS AND 5 OUT OF 8 RESULTED COMPATIBLE. HOWEVER WHEN SHE ANTIGEN TYPED THE UNITS WITH ANTI-C ANTISERA, 4 OF THE UNITS WERE (B)(4) FOR THE C ANTIGEN. CUSTOMER DID NOT PERFORM CROSSMATCH TESTING ON THE UNITS BY MANUAL TUBE METHOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GALILEO ECHO AUTOMATED BLOOD BANK ANALYZER KSZ IMMUCOR, INC. M00792

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR