BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY SCREEN 3

    MDR report key: 1709955 · Received June 4, 2010

    Report

    Report Number
    1034569-2010-00120
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 5, 2010
    Report Date
    June 3, 2010
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    STN 102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CONFIRMED THE REACTIVITY OF THE FYA ANTIGEN ON RETENTION CRRS3 LOT R084 USING ANTI-FYA. PERFORMED ANTIBODY SCREENING ASSAY WITH RETURNED SAMPLE BY MANUAL CAPTURE USING RETENTION CAPTURE-R READY-SCREEN (3), LOT R084. RETURNED SAMPLE EXHIBITED NEGATIVE REACTIVITY WITH ALL CELLS TESTED. THE SAMPLE WAS TESTED WITH SELECTED FY(A+B+), FY(A+B-) AND FY(A-B-) REAGENT RED CELLS FROM RETENTION PANOCELL-16, LOT 14088, USING IMMUAD AS THE POTENTIATOR. A ROOM TEMPERATURE INCUBATION WAS INCLUDED. THE SAMPLE EXHIBITED WEAK REACTIVITY WITH FY(A+B-); VERY WEAK TO MICROSCOPIC REACTIVITY WITH FY(A+B+), AND NO REACTIVITY WITH FY(A-B-) REAGENT RED CELLS AS EXPECTED, ONLY AT THE INDIRECT ANTIGLOBULIN TEST. PER THE CRRS 3 PACKAGE INSERT, "NEGATIVE REACTIONS WILL BE OBTAINED IF THE TEST SERUM CONTAINS ANTIBODIES PRESENT IN CONCENTRATIONS TOO LOW TO BE DETECTED BY THE TEST METHODS EMPLOYED."

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE RESULTS WHEN TESTING SAMPLES WITH CAPTURE-R READY SCREEN 3 (CRRS 3). THE SAMPLE HAD A KNOWN ANTI-FYA. REPEAT TESTING WITH A 30 MINUTE INCUBATION RESULTED POSITIVE(1+) ONLY WITH HOMOZYGOUS FYA CELLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY SCREEN 3 REAGENT RED BLOOD CELLS KSZ IMMUCOR R084

    Patients

    Seq Age Sex Outcome Treatment
    1