BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 8046737 · Received November 7, 2018

    Report

    Report Number
    1034569-2018-00251
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 4, 2018
    Report Date
    November 1, 2018
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018 AN IMMUCOR TECHNICIAN INSPECTED ECHO INSTRUMENT AND THE UNIT WAS OPERABLE UPON ARRIVAL. THE IMMUCOR TECHNICIAN PERFORMED THE UNEXPECTED REACTION CHECKLIST WAS PERFORMED AND HAD ACCEPTABLE RESULTS. THE IMMUCOR TECHNICIAN DISCOVERED THAT THE WASHER MANIFOLD HAD A LOOSE CONNECTION AND WAS LEAKING, SO THEY REPLACED THE WASHER MANIFOLD. THE IMMUCOR TECHNICIAN THEN RAN RESIDUAL VOLUME AND WASHER ACCURACY AND RAN QC AND ANTI E PATIENT WITH ACCEPTABLE RESULTS (ANTI-E SAMPLE HAD A POSITIVE REACTION IN SCREEN RESULTS FOR LOT R004. THE INSTRUMENT WAS TESTED AND OPERATED WITHIN SPECIFICATIONS WITH NO PROBLEMS OBSERVED SO WAS RELEASED FOR CUSTOMER USE. ON (B)(6) 2018 IMMUCOR PERFORMED AN ANTIBODY SCREEN ON THE ECHO LUMENA WITH RETURNED CUSTOMER SAMPLE "E QC" USING RETENTION CAPTURE-R READY SCREEN (3) LOT R004 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221200. CONTROLS PERFORMED AS EXPECTED. RETURN SAMPLE RESULTED 3+ WITH CELL 2 AND (B)(6) WITH CELLS 1 AND 3 (CELL 2 IS E+). THE IMMUCOR INTERNAL REPORT RECORD NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2018 A CUSTOMER REPORTED UNEXPECTED (B)(6) ANTIBODY SCREENING RESULTS WITH CAPTURE-R READY-SCREEN 3 ON THE ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888924 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R004 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1