BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY ID

    MDR report key: 1080700 · Received July 25, 2008

    Report

    Report Number
    1034569-2008-00272
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 17, 2008
    Manufacturer
    IMMUCOR, INC.
    Product Code
    KSZ
    PMA / PMN Number
    102707 STN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    REACTIIVTY OF THE FYA ANTIGEN WAS CONFIRMED ON RETENTION CRRS, LOT K121 AND CRRID, LOT ID079. THE CUSTOMER'S RETURNED SAMPLES WERE TESTED BY HA WITH SELECTED FY(A+B+) AND FY(A-) REAGENT RED CELLS, USING IMMUADD, LOT 5B5503, AS THE POTENTIATOR. VERY WEAK REACTIVITY WAS OBSERVED WITH BOTH SAMPLES WITH FY(A+B+) CELL AT IAT. THE FY(A-) CELL WAS NONREACTIVE, AS EXPECTED. MANUAL SOLID PHASE TESTING WAS PERFORMED WITH THE CUSTOMER'S SAMPLES AND 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 NONREACTIVITY WITH FY(A+B+) CELLS. THE OTHER SAMPLE EXHIBITED NEGATIVE TO WEAK REACTIVITY WITH FY(A+B-) CELLS AND NONREACTIVITY WITH FY(A+B+) CELLS. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION. THE PATIENT'S ANTIBODY IS SHOWING DOSAGE EFFECT; THE EVENT APPEARS TO BE CAUSED BY THE NATURE OF THE SAMPLE. THE PACKAGE INSERTS FOR CAPTURE-R READY ID AND CRRS 4 STATE "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 A FALSE NEGATIVE REACTION WITH CAPTURE R READY SCREEN (CRRS) 4 ON GALILEO. A PATIENT SAMPLE KNOWN TO CONTAIN ANTI-FYA WAS NEGATIVE WHEN TESTED WITH CRRS 4.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1