BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN 3

    MDR report key: 2181866 · Received July 28, 2011

    Report

    Report Number
    1034569-2011-00103
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 26, 2011
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF INSTRUMENT RESULTS: ALL CELLS FROM CRRS3 LOT R161-NO RED CELL ADHERENCE, NICE TIGHT BUTTON, POS CONTROL WELL ACCEPTABLE, STRONG ADHERENCE CELL 2(E+/E=) CELL 1&3 (E=/E+) ALL CELL FROM CRRID EXTEND II- DN047- NO RED CELL ADHERENCE, NICE TIGHT BUTTON POS CONTROL WELL ACCEPTABLE STRONG ADHERENCE CELL 2&3(E+/E+) ALL OTHER CELLS (E=/E+) ALL SAMPLES TESTED PRIOR TO THIS SAMPLE AND AFTER THIS SAMPLE HAVE RESULTED AS EXPECTED. CONFIRMED THE REACTIVITY OF THE E ANTIGEN ON RETENTION CAPTURE-R READY-SCREEN (3), LOT R161 AND CAPTURE-R READY-ID EXTEND, LOT DN047 USING RETENTION CAPTURE-R READY INDICATOR RED CELLS LOT 221689 AND ANTI-E LOT 7D630 (1:16 DILUTION). CONTROLS PERFORMED AS EXPECTED AND PRODUCT EXHIBITED THE EXPECTED REACTIVITY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS ON WHEN TESTING A PATIENT SAMPLE WITH CAPTURE-R READY SCREEN 3 (CRRS3) AND CAPTURE-R READY-ID (CRRID) EXTEND II ON THE ECHO. PATIENT HAS A KNOWN ANTI E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R161

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR