BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 5285494 · Received December 10, 2015

    Report

    Report Number
    1034569-2015-00204
    Event Type
    Malfunction
    Date Received
    December 10, 2015
    Date of Event
    November 13, 2015
    Report Date
    December 9, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT REVIEWED INSTRUMENT IMAGES OBTAINED BY USING A REMOTE ELECTRONIC CONNECTION METHOD. SAMPLE (B)(6) ON ECHO SN (B)(4) SHOWS THE FOLLOWING: BATCH 48789 TESTED ON (B)(4) 2015, USING LOTS R671 & CRRIC 221473. LOT R671: THE FOLLOWING CELLS ARE JKA+ 1(HOMOZYGOUS) AND 2(HETEROZYGOUS). POSITIVE REACTIONS FOR CELL 1 REACTION STRENGTH: 1+ ), VISUALLY POSITIVE. NEGATIVE REACTIONS FOR CELLS 2 & 3 , VISUALLY POSITIVE. SAMPLE 798434 ON ECHO SN (B)(4) SHOWS THE FOLLOWING: BATCH 48794 TESTED ON (B)(6) 2015, USING LOTS R671 & CRRIC 221473 . LOT R671: THE FOLLOWING CELLS ARE JKA+ 1(HOMOZYGOUS) AND 2(HETEROZYGOUS). NEGATIVE REACTIONS FOR ALL CELLS. * CELL 1 VISUALLY POSITIVE. CELL 2: VISUALLY EQUIVOCAL CELL 3: VISUALLY NEGATIVE. CUSTOMER WAS ADVISED THAT PER CUSTOMER COMMUNICATION (B)(4) WE ARE AWARE OF SOME INSTANCES ON THE ECHO WHERE THE INSTRUMENT MAY GENERATE A NEGATIVE WELL INTERPRETATION FOR CAPTURE-R® READY-SCREEN® OR CAPTURE-R® READY-ID® ASSAYS AND SUBSEQUENT VISUAL INTERPRETATION OF THOSE REACTIONS ARE WEAK POSITIVE OR QUESTIONABLE (EQUIVOCAL).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN TESTING A PATIENT SAMPLE ON A GALILEO ECHO. ANTI-JKA WAS IDENTIFIED WHEN THE SAMPLE WAS TESTED BY CAPTURE-R READY-ID (CRRID) PANEL ON ECHO AND BY MANUAL TUBE TESTING (PEG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814856 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR