BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPTURE-R READY-ID TEST WELLS

    MDR report key: 885615 · Received June 25, 2007

    Report

    Report Number
    1034569-2007-00176
    Event Type
    Malfunction
    Date Received
    June 25, 2007
    Date of Event
    June 27, 2007
    Report Date
    July 25, 2007
    Manufacturer
    IMMUCOR
    Product Code
    KSZ
    PMA / PMN Number
    102707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RAN THE SAMPLE USING THE EXTEND DP ASSAY WITH THE SAME REAGENTS AND THE RESULTS SUGGESTED A DEFINITIVE ANTI-JKA. HETEROZYGOUS JKS CELLS 3 AND 14 SHOWED A 4+ REACTIVITY. THE PRESENCE OF THE JKA ANTIGEN WAS CONFIRMED ON RETENTION CAPTURE-R READY-ID (CRRID), LOT ID084. CUSTOMER SENT SAMPLE FOR INVESTIGATION TESTING. TESTING WAS PERFORMED WITH THE SAMPLE AND RETENTION CRRID, LOT ID084. NO UNEXPECTED NEGATIVE REACTIONS WERE OBSERVED. THE SAMPLE EXHIBITED MODERATE TO STRONG REACTIVITY WITH ALL JK(A+) AND K+ CELLS. K+/ JK(A-) CELLS WERE NONREACTIVE, AS EXPECTED. DUE TO LIMITED SAMPLE VOLUME AND THE 4+ HEMOLYSIS OBSERVED IN PLASMA, GALILEO TESTING WAS NOT PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED UNEXPECTED NEGATIVE REACTIONS WHEN TESTING A PATIENT SAMPLE ON GALILEO USING CAPTURE-R READY-ID; AN ANTI-JKA WAS NONREACTIVE WITH SOME CELLS IN THE ABID ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTURE-R READY-ID TEST WELLS REAGENT RED BLOOD CELLS KSZ IMMUCOR ID084

    Patients

    Seq Age Sex Outcome Treatment
    1 YR