BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 5594167 · Received April 21, 2016

    Report

    Report Number
    1034569-2016-00082
    Event Type
    Malfunction
    Date Received
    April 21, 2016
    Date of Event
    March 22, 2016
    Report Date
    April 20, 2016
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    UDI-DI
    10888234000648
    PMA / PMN Number
    102707/0.0
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR PERSONNEL REVIEWED THE INSTRUMENT CAMERA IMAGE REMOTELY: ALL 3 SCREEN CELLS RESULTED NEGATIVE AND WERE VISUALLY NEGATIVE. CELL 1 JK(A-B+) CELL 2 JK(A+B-) CELL 3 JK(A+B-) ON (B)(6) 2016 PI LAB CONFIRMED THE REACTIVITY OF THE JKA ANTIGEN ON RETENTION CRRS (3) LOT R717 CELL I AND CELL III WITH RETENTION ANTI-JKA LOT 614007-1 (DILUTION 1:1). CONTROLS PERFORMED AS EXPECTED. CELL I AND CELL III EXHIBITED 4+ REACTIVITY. THE UNEXPECTED NEGATIVE RESULTS APPEAR TO BE DUE TO THE NATURE OF THE SAMPLE.

    Description of Event or Problem · 1

    ON (B)(6) 2016, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN TESTING A SAMPLE USING CAPTURE-R READY-SCREEN 3 (CRRS 3) ON A GALILEO NEO INSTRUMENT. PATIENT HAS A HISTORY OF ANTI-JKA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249735 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R717 10888234000648

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR