BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY INDICATOR RED CELLS

    MDR report key: 4258561 · Received November 18, 2014

    Report

    Report Number
    1034569-2014-00207
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 20, 2014
    Report Date
    November 17, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    BK020053
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    IMMUCOR TECHNICAL SUPPORT USED A REMOTE ELECTRONIC CONNECTION METHOD TO ASSESS THE INSTRUMENT TEST WELL IMAGES. BATCH 27350 TESTED ON (B)(6) 2014 USING LOTS R474 IC 221242; NEGATIVE REACTIONS FOR CELLS 1,2,3 VISUALLY NEGATIVE. CAPTURE-R READY INDICATOR RED CELL (CRRIRC), LOT 221242, EXPIRED PRIOR TO COMPLAINT BEING REFERRED TO PI. PRODUCT WAS NOT USED ON THE ECHO WHILE IN DATE. DHR REVIEW: -- SCREEN ASSAY WAS PERFORMED ON (B)(6) 2014 USING CRRS3 LOT R456 ON ECHO INSTRUMENT; -- CONTROLS PERFORMED AS EXPECTED. WBCORQC LEVEL 2 CONTAINS ANTI-D. RESULTS WERE 4+ WITH CELL 1, 4+ WITH CELL 2, AND NEGATIVE WITH CELL 3. CELLS 1 AND 2 ARE D ANTIGEN POSITIVE. CELL 3 IS D ANTIGEN NEGATIVE. -- 4 REPLICATES OF CAPTURE-R NEGATIVE CONTROL, LOT 245140L, RESULTED NEGATIVE AS EXPECTED. -- 4 REPLICATES OF CAPTURE-R POSITIVE CONTROL (WEAK), LOT 244290, RESULTED POSITIVE AS EXPECTED. -- 4 REPLICATES OF KNOWN ANTIBODY NEGATIVE (INERT) IN-HOUSE DONORS RESULTED NEGATIVE AS EXPECTED. CRRIRC LOT 221242 PERFORMED AS EXPECTED. DHR QUALITY REVIEW DEEMED ALL SPECIFICATIONS AS BEING MET AND RELEASED PRODUCT TO MARKET ON 12SEP2014.

    Description of Event or Problem · 1

    ON (B)(6) 2014, A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN ASSAY WHEN TESTING A PATIENT SAMPLE USING CAPTURE-R READY INDICATOR RED CELLS (CRRIRC) ON A GALILEO ECHO INSTRUMENT. THE PATIENT IS O NEGATIVE AND HAS A KNOWN ANTI D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744711 CAPTURE-R READY INDICATOR RED CELLS ANTIGLOBULIN COATED RED CELLS KSZ IMMUCOR, INC. 221242

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR