BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN 3

    MDR report key: 2189796 · Received August 3, 2011

    Report

    Report Number
    1034569-2011-00107
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 3, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT RESULTS: SCI APPEARED 1+; SCIII APPEARED 1+; POSITIVE CONTROL REACTED AS EXPECTED. SCI JK(A+B+) SCII JK(A-B+) SCIII JK(A+B-). NOTE: GROUP REVERSE WELLS APPEARED ICTERIC. THE CUSTOMER DID NOT SUBMIT SAMPLE OR PRODUCT FOR INVESTIGATION. CONFIRMED THE REACTIVITY OF THE JKA ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN 3 (CRRS3) LOT R163 USING RETENTION CAPTURE-R READY INDICATOR RED CELLS (CRRIRC) LOT 221687 AND ANTI-JKA QC (1:125 DILUTION). CONTROLS PERFORMED AS EXPECTED AND ALL REAGENT RED CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS3) ON THE ECHO. THE PATIENT HAD A PREVIOUSLY KNOWN JKA ANTIBODY. THE SAMPLE WAS TESTED WITH AN ID PANEL WHICH REACTED POSITIVE WITH JKA CELLS WITH 1+ TO 3+ REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R163

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR