BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 3797425 · Received May 7, 2014

    Report

    Report Number
    1034569-2014-00071
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 2, 2014
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707/5045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. REVIEW OF BATCH FILE (B)(6) SHOWS SAMPLE ENDING IN (B)(6) WITH ALL NEGATIVE WELLS. VISUAL INTERPRETATION MATCHES THE INSTRUMENT. CUSTOMER USED R390 WITH CRRIC 221149. REVIEW OF BATCH FILE (B)(6) SHOWS SAMPLE ENDING IN (B)(6) WITH ALL NEGATIVE WELLS. VISUAL INTERPRETATION MATCHES THE INSTRUMENT. CUSTOMER USED R390 WITH CRRIC 221153. REVIEW OF BATCH FILE (B)(6) SHOWS SAMPLE ENDING IN (B)(6) WITH ALL NEGATIVE WELLS. VISUAL INTERPRETATION MATCHES THE INSTRUMENT. CUSTOMER USED R389 WITH CRRIC 221153. CBC TUBE FROM PATIENT WAS TESTED ON THIS BATCH AS WELL AND SHOWS NEGATIVE REACTIONS IN ALL WELLS. VISUAL INTERPRETATION MATCHES THE INSTRUMENT. REVIEW OF BATCH FILE (B)(6) SHOWS SAMPLE ENDING IN (B)(6) WITH 2+ REACTION IN WELL 1, EQUIVOCAL REACTIONS IN WELLS 2 AND 5, 3+ REACTION IN WELL 13 AND NEGATIVE REACTIONS IN ALL REMAINING WELLS. VISUAL INTERPRETATION MATCHES THE INSTRUMENT. CUSTOMER IS USING CRRID ID211 WITH CRRIC 221153. RETENTION SAMPLE TESTING: CONFIRMED THE REACTIVITY OF THE FYB ANTIGEN ON CELL 1 OF RETENTION CAPTURE-R READY SCREEN 3 PLATES LOT R390 USING RETENTION ANTI-FYB LOT 613010 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221153. CONTROLS PERFORMED AS EXPECTED AND CELL 2 WAS FYB POSITIVE AS EXPECTED. RETENTION PRODUCT PERFORMED AS EXPECTED. RETURNED SAMPLE TESTING: PERFORMED AN ANTIBODY SCREEN ON RETURNED SAMPLES (B)(6) USING RETENTION CAPTURE- R READY SCREEN 3 PLATES LOT R390 AND RETENTION CAPTURE-R INDICATOR CELLS LOT 221153. CONTROLS PERFORMED AS EXPECTED AND ALL RETURNED SAMPLES WERE NEGATIVE. SAMPLE (B)(6) GAVE A NEGATIVE REACTION IN CELL 2, BUT THE CELL BUTTON WAS FUZZY WITH RED CELL ADHERENCE. REPRODUCED CUSTOMER RESULTS. NO PRODUCT DEFICIENCY IDENTIFIED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 A CUSTOMER REPORTED AN UNEXPECTED NEGATIVE ANTIBODY SCREEN WHEN USING CAPTURE-R READY-SCREEN (3) (CRRS 3) LOT R390 ON A GALILEO ECHO INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274605 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELLS KSZ IMMUCOR, INC. R390

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR