BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 11039727 · Received December 18, 2020

    Report

    Report Number
    1034569-2020-00060
    Event Type
    Malfunction
    Date Received
    December 18, 2020
    Date of Event
    November 14, 2020
    Report Date
    December 18, 2020
    Manufacturer
    IMMUCOR, INC.
    Product Code
    QHT
    UDI-DI
    10888234001454
    PMA / PMN Number
    BL 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2020 IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ACCESS GALILEO NEO SERIAL NUMBER (B)(4). REVIEW OF THE (B)(6) 2020 RESULTS CONFIRMED THAT VISUALLY IT APPEARED TO BE NEGATIVE; NO ERRORS WERE NOTED IN EVENT LOG. ON (B)(6) 2020 AN IMMUCOR FIELD SERVICE ENGINEER (FSE) EXAMINED THE INSTRUMENT AT THE CUSTOMER SITE. THE FSE COMPLETED THE UNEXPECTED REACTIONS CHECKLIST SUCCESSFULLY. THE FSE ADJUSTED THE ROI'S AND COMPLETED DAILY MAINTENANCE. THE FSE THEN RAN ABO AND 3 CELL SCREEN QC WHICH RETURNED QUALIFIED RESULTS. THE FSE ALSO RAN ABO AND 3 CELL SCREEN ASSAYS ON 4 PATIENT SAMPLES WHICH PROVIDED ACCEPTABLE RESULTS. ON NOVEMBER 23, 2020 IMMUCOR CONFIRMED PRESENCE OF THE JKA ANTIGEN ON CELLS 1 AND 2 OF RETENTION CAPTURE-R READY-SCREEN LOT R180 IN MANUAL CAPTURE USING RETENTION CAPTURE-R INDICATOR CELL LOT 221660 WITH RETENTION ANTI-JKA LOT DL189543. CONTROLS PERFORMED AS EXPECTED. CELLS 1 AND 2 RESULTED POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    ON (B)(6) 2020 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULT WITH CAPTURE-R READY-SCREEN 3 ON THE GALILEO NEO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503453 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS QHT IMMUCOR, INC. R180 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1