BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID

    MDR report key: 834830 · Received February 9, 2007

    Report

    Report Number
    1034569-2007-00028
    Event Type
    Malfunction
    Date Received
    February 9, 2007
    Date of Event
    January 16, 2007
    Report Date
    February 9, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER SENT TWO SAMPLES FROM THE PT FOR INVESTIGATION TESTING. THE PRESENCE OF THE FYA ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY-SCREEN (CRRS), LOT K121 AND CRRID, LOT ID079. HEMAGGLUTINATION TUBE TESTING WAS PERFORMED WITH PT SAMPLES USING FY (A+B+) AND FY(A-) REAGENT RED BLOOD CELLS AND IMMUADD AS POTENTIATOR. VERY WEAK REACTIVITY WAS OBSERVED WITH THE FY (A+B+) CELLS AT ANTIGLOBULIN PHASE. THE FY(A-) CELL WAS NONREACTIVE, AS EXPECTED. MANUAL TESTING WAS PERFORMED WITH THE PT SAMPLES USING RETENTION CRRS, LOT K121 FY(A+B-) CELL III AND FY(A-) CELL IV AND CRRID, LOT ID079 FY(A+B+) CELL #2, FY(A-B-) CELL #4, AND FY (A+B-) CELL #6. ALL FY (A-) CELLS WERE NONREACTIVE, AS EXPECTED. ONE SAMPLE EXHIBITED VERY WEAK TO WEAK REACTIVITY WITH FY (A+B-) CELLS AND NEGATIVE REACTIVITY WITH FY(A+B+) CELLS. THE OTHER SAMPLE EXHIBITED NEGATIVE TO WEAK REACTIVITY WITH FY (A+B-) CELLS AND NEGATIVE REACTIVITY WITH FY (A+B+) CELLS.THE EVENT APPEAR TO BE RELATED TO THE NATURE OF THE SAMPLE. THE LIMITATIONS SECTION OF THE CAPTURE-R READY-SCREEN AND CAPTURE-R READY-ID PACKAGE INSERTS STATES, "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 REACTIONS WHEN PERFORMING ANTIBODY TESTING ON THE GALILEO USING CAPTURE-R READY-SCREEN 4, LOT K121 AND CAPTURE-R READY-ID, LOT ID079 ON A PT SPECIMEN WITH HISTORY OF ANTI-FYA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-ID REAGENT RED BLOOD CELLS KSZ IMMUCOR * ID079

    Patients

    Seq Age Sex Outcome Treatment
    1 *