BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 8847366 · Received July 31, 2019

    Report

    Report Number
    1034569-2019-00124
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 15, 2019
    Report Date
    July 31, 2019
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234001454
    PMA / PMN Number
    BL102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON JULY 22, 2019 IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS FILES ON GALILEO ECHO V2.0 INSTRUMENT SERIAL NUMBER (B)(4); THE CAMERA REPORT WAS ACCEPTABLE. JULY 23, 2019 IMMUCOR CONFIRMED PRESENCE OF THE E ANTIGEN ON CELL 2 OF RETENTION CAPTURE-R READY-SCREEN 3 LOT NUMBER R067 IN MANUAL CAPTURE RETENTION USING CAPTURE-R READY INDICATOR CELLS LOT NUMBER 221869 WITH RETENTION ANTI-E LOT AB4929. CONTROLS PERFORMED AS EXPECTED. CELL 2 RESULTED POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. ON JULY 24, 2019 IMMUCOR PERFORMED AN ANTIBODY SCREEN ON RETURNED PATIENT SAMPLE WITH AN ECHO LUMENA USING RETENTION CAPTURE-R READY-SCREEN 3 LOT NUMBER R067 AND CAPTURE-R READY INDICATOR CELLS LOT NUMBER 221869. CONTROLS PERFORMED AS EXPECTED AND RETURN SAMPLE RESULTED POSITIVE WITH CELL2 (E+E=). THE CUSTOMER ISSUE WAS NOT REPRODUCED. RETENTION PRODUCT PERFORMED AS EXPECTED. THE IMMUCOR INTERNAL REPORT RECORD NUMBER FOR THIS REPORT IS MDR723820.

    Description of Event or Problem · 1

    ON JULY 22, 2019 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE SCREEN RESULT USING CAPTURE-R READY-SCREEN 3 ON THE GALILEO ECHO V2.0 INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640511 CAPTURE-R READY-SCREEN 3 AUTOMATED BLOOD BANK SYSTEM KSZ IMMUCOR, INC. R067 10888234001454

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR