BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-SCREEN 3

    MDR report key: 1518427 · Received October 30, 2009

    Report

    Report Number
    1034569-2009-00379
    Event Type
    Malfunction
    Date Received
    October 30, 2009
    Date of Event
    September 30, 2009
    Report Date
    October 29, 2009
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF RESULT FILES- CRRS 3 LOT R056 WELL 1 (8) WELL 2 (40) WELL 3 (0) WELL 4 (100)- CONTROLS, VISUALLY OPTIMAL, WELL 1 SLIGHT HALO, SMALL BUTTON, WELL 2, MODERATE ADHERENCE WELL 3 -NEGATIVE PHENOTYPE- WELL 1JKA+JKB- WELL 2 JKA+JKB- WELL 3 JKA-JKB+CRRID LOT ID119RAW SCORES 1,2,1,2,2,8,1,1,0,1,1,40,1,1,100,0 - VISUAL INSPECTION CONTROLS, OPTIMAL. AGREE WITH INSTRUMENT ASSESSMENT. PHENOTYPE- WELL 2 JKA+JKB- WELL 4 JKA+JKB+ WELL 5 JKA+JKB+ WELL 6 JKA+JKB- WELL 11JKA+JKB+ WELL 12 JKA+JKB- WELL 13 JKA+JKB+ WELL 14 JKA+JKB+. THE REACTIVITY OF THE JKA ANTIGEN WAS CONFIRMED ON RETENTION CRRS(3), LOT R056 AND RETENTION CRRID, LOT ID119 WITH ANTI-JKA.THE REACTIVITY OF THE JKA ANTIGEN WAS CONFIRMED ON RETURNED CRRS(3), LOT R056 AND RETURNED CRRID, LOT ID119 WITH ANTI-JKA.THE SUBMITTED PLASMA SAMPLE (REPORTEDLY ANTI-JKA) WAS TESTED WITH RETURNED AND RETENTION CRRS(3), LOT R056 ON IN-HOUSE ECHO. THE SAMPLE EXHIBITED EQUIVOCAL, BUT VISUALLY POSITIVE REACTIVITY WITH CELL I AND CELL II, JK(A+) RED CELLS WITH RETURNED R056. THE SAMPLE EXHIBITED EQUIVOCAL, BUT VISUALLY POSITIVE REACTIVITY WITH CELL I AND 2+ REACTIVITY WITH CELL II, JK(A+) RED CELLS WITH RETENTION R056. A SERVICE CALL WAS MADE. THE ISSUE WAS RESOLVED BY REPLACING THE CAMERA READER. THE SYSTEM WAS TESTED AND OPERATES WITHIN SPECIFICATIONS WITH NO PROBLEMS OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A SAMPLE TESTED WITH CAPTURE-R READY SCREEN 3 (CRRS 3) AND CAPTURE-R READY ID (CRRID) WAS INTERPRETED AS NEGATIVE BY THE ECHO BUT WELLS APPEAR VISUALLY POSITIVE. CUSTOMER STATES THAT THE PATTERN FITS WITH A ANTI-JKA. CUSTOMER DOES NOT HAVE HISTORY ON THIS PATIENT. THIS IS THE FIRST TIME AN ANITBODY HAS BEEN IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR R056

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR