BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN 3

    MDR report key: 1052405 · Received May 29, 2008

    Report

    Report Number
    1034569-2008-00162
    Event Type
    Malfunction
    Date Received
    May 29, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 19, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE REACTIVITY OF THE JKA ANTIGEN WAS CONFIRMED ON RETENTION CRRS(3), LOT R022 AND CRRID, LOT ID100. THE REACTIVITY OF THE JKA ANTIGEN WAS CONFIRMED ON RETURNED CRRS(3), LOT R022.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WITH CELL #III, HOMOZYGOUS JKA CELL, OF CAPTURE-R READY SCREEN (CRRS) 3 , LOT #R022, WHEN TESTING A PATIENT SAMPLE CONTAINING ANTI-JKA ON THE ECHO. NO ADVERSE REACTIONS OR TRANSFUSION REACTIONS OCCURRED AS A RESULT OF THE UNEXPECTED NEGATIVE REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN 3 REAGENT RED BLOOD CELS KSZ IMMUCOR, INC. R022

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR