BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN (3)

    MDR report key: 2935730 · Received January 30, 2013

    Report

    Report Number
    1034569-2013-00028
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 28, 2013
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULT FILES WERE REVIEWED BY AN IMMUCOR TECHNICAL SUPPORT SPECIALIST. THE INITIAL ANTIBODY SCREEN RESULTED AS NEGATIVE. CELL 2 VISUALLY APPEARED POSITIVE [CUSTOMERS WERE MADE AWARE OF TECHNICAL COMMUNICATION (B)(4) WHICH ADVISES CUSTOMERS TO VISUALLY INSPECT ALL NEGATIVE ANTIBODY SCREENING AND IDENTIFICATION RESULTS ON THE ECHO PRIOR TO RELEASE OF RESULTS]. THE CUSTOMER WAS ASKED TO REPEAT THE SCREEN USING A DIFFERENT LOT OF TEST WELLS. POSITIVE (2+) REACTIONS WERE OBTAINED IN WELLS 1 AND 3 AND NEGATIVE IN WELL 2 AS EXPECTED. THE IMMUCOR PRODUCT INVESTIGATIONS LAB CONFIRMED THE PRESENCE OF THE FYA ANTIGEN ON RETENTION CRRS(3), LOT R271 WITH ANTI-FYA, LOT 607009 DILUTED 1:16, USING RETENTION CRRIRC, LOT 221920. CONTROLS PERFORMED AS EXPECTED AND REAGENT RED BLOOD CELLS TESTED EXHIBITED THE EXPECTED REACTIVITY. RETENTION PRODUCTS PERFORMED AS EXPECTED. THE PRESENCE OF THE FYA ANTIGEN ON RETURNED PRODUCT (LOT R271) WAS ALSO CONFIRMED. CONTROLS PERFORMED AS EXPECTED AND REAGENT RED BLOOD CELLS EXHIBITED THE EXPECTED REACTIVITY. RETURNED PRODUCTS PERFORMED AS EXPECTED. NO SAMPLE WAS SUBMITTED FOR INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT UNEXPECTED NEGATIVE REACTIVITY WAS OBTAINED WITH THE CAPTURE-R READY-SCREEN (3) ASSAY ON THE GALILEO ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40999 CAPTURE-R READY-SCREEN (3) REAGENT RED BLOOD CELL KSZ IMMUCOR, INC. R271

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR