BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN I AND II

    MDR report key: 5594158 · Received April 21, 2016

    Report

    Report Number
    1034569-2016-00080
    Event Type
    Malfunction
    Date Received
    April 21, 2016
    Date of Event
    March 24, 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
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR REVIEWED CUSTOMER INSTRUMENT CAMERA IMAGES REMOTELY: CELL 2: E+(HOMOZYGOUS). SAMPLE ID (B)(6): NEGATIVE RESULTS FOR BOTH CELLS, VISUALLY NEGATIVE ON (B)(6) 2016 THE PI LAB CONFIRMED REACTIVITY OF THE E ANTIGEN ON CELL 2 ((B)(6)) OF RETENTION CAP R RS I,II LOT X441 IN MANUAL CAPTURE USING RETENTION CAPTURE-R READY INDICATOR RED CELLS LOT 221599 WITH RETENTION ANTI-E LOT 8A631-1-C (1:128 DILUTION). CONTROLS PERFORMED AS EXPECTED. POSITIVE RESULTS EXHIBITED 4+ REACTIVITY. RETENTION PRODUCT PERFORMED AS EXPECTED.

    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 I AND II (CRRS I,II) ON A GALILEO NEO INSTRUMENT. PATIENT HAS PREVIOUS HISTORY OF ANTI-E, ANTI-C, AND ANTI-CW. CURRENTLY ONLY ANTI-E IS REACTING. THE NEO IS IN THE PROCESS OF BEING VALIDATED AND NOT USED FOR ACTUAL PATIENT TESTING. SAMPLE NUMBER USED FOR ALL TESTING IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250998 CAPTURE-R READY-SCREEN I AND II REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. X441 10888234000648

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR