BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GALILEO ECHO

    MDR report key: 5020883 · Received August 21, 2015

    Report

    Report Number
    1034569-2015-00118
    Event Type
    Malfunction
    Date Received
    August 21, 2015
    Date of Event
    July 24, 2015
    Report Date
    August 21, 2015
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK070016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE TEST WELL IMAGES ON THE ECHO. TESTING WAS PERFORMED ON 11 JUN 2015 ON THE ECHO. TESTING WAS FOR VALIDATION PURPOSES. ON BATCH (B)(4) SAMPLE (B)(4) USING LOTS R608/221402/LISS 211590: CELL 1 NEG VISUALLY NEG, CELL 2 NEG VISUALLY POS, CELL 3 NEG VISUALLY POS, CTRL WELL REACTED AS EXPECTED. CELL 1 C-, CELL 2 C-C+, CELL 3 C-C+. ON BATCH (B)(4) SAMPLE (B)(4) USING LOTS R608/221402/LISS 211590 (SAME VIAL OF CRRIC LOT ON BATCH (B)(4)): CELL 1 NEG VISUALLY POS, CELL 2 NEG VISUALLY POS, CELL 3 NEG VISUALLY NEG, CTRL WELL REACTED AS EXPECTED. CELL 1 AND 2 D+ CELL 3 D-. ON BATCH (B)(4) SAMPLE (B)(4) USING LOTS R608/221402/LISS 211590 (SAME VIAL OF CRRIC LOT ON BATCH (B)(4)): CELL 1 NEG VISUALLY POS, CELL 2 NEG VISUALLY POS, CELL 3 NEG VISUALLY NEG, CTRL WELL REACTED AS EXPECTED. CELL 1 AND 2 D+ CELL 3 D-. CUSTOMERS WERE NOTIFIED OF VISUALLY POSITIVE RESULTS WITH CAPTURE-R PRODUCTS WHICH ARE INTERPRETED NEGATIVE BY THE ECHO IN CUSTOMER COMMUNICATION (B)(4) IN NOVEMBER 2009.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING A SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS3) ON THE ECHO. TESTING WAS PERFORMED ON 3 SAMPLES FOR VALIDATION PURPOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555002 GALILEO ECHO AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1