BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTO-STAT® TETRACHROME¿ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5

    MDR report key: 2446584 · Received February 10, 2012

    Report

    Report Number
    1061932-2012-00483
    Event Type
    Malfunction
    Date Received
    February 10, 2012
    Date of Event
    January 12, 2012
    Report Date
    January 12, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030828
    Removal / Correction Number
    Z-1876-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMANCE CAPABILITY OF THE TETRACXP REAGENT WAS ASSESSED USING EXISTING AGED SPECIMEN/PREPARED SAMPLE STABILITY STUDY DATA. RESULTS SHOWED AGED SAMPLE VARIATION TAKES UP THE MAJORITY OF THE VARIATION IN THE INTERNAL SPECIFICATION AND NO OTHER ERROR BUDGET IS LEFT FOR OTHER SYSTEM VARIATION. THEREFORE, THE SPECIFICATION AND/OR CLAIMS ARE INADEQUATE AND A NEW AGED SAMPLE/PREPARED SAMPLE STABILITY SPECIFICATION AND CLAIM NEEDED TO BE DEVELOPED. NEW AGED SPECIMEN/PREPARED SAMPLE STABILITY CLAIMS ARE UNDER DEVELOPMENT. CHARACTERIZATION STUDIES SHOW THAT CLAIMS OF 24 HOUR AGED SPECIMEN AND 24 HOUR PREPARED SAMPLE STABILITY SHOULD BE SUPPORTED FOR TETRACXP MANUAL APPLICATION. THIS WAS AN IN-HOUSE STABILITY STUDY FOR THE DOCUMENTED REAGENT AND IS NOT LOT SPECIFIC. (B)(4). THIS MEDWATCH REPORT IS RELATED TO MDR 1061932-2012-00490.

    Description of Event or Problem · 1

    BASED UPON INTERNAL DEVELOPMENT ACTIVITIES, INCLUDING INPUT FROM BECKMAN COULTER, INC. (B)(4), A REVIEW OF TETRACXP REAGENT PERFORMANCE STUDIES IDENTIFIED THE INTERNAL PERFORMANCE SPECIFICATION OF +/-5% FOR PERCENT POSITIVE RESULTS - USED AS ACCEPTANCE CRITERIA FOR ACCURACY AND AGED SPECIMEN/PREPARED SAMPLE STABILITY STUDIES - ALLOWS FOR GREATER VARIATION THAN THE CURRENT (B)(4) GUIDELINE FOR CD4 (CLUSTER OF DIFFERENTIATION 4) PARAMETER (+/-3%). PATIENT RESULTS WERE NOT ASSOCIATED. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYTO-STAT® TETRACHROME¿ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 TETRACXP SYSTEM FOR THE CYTOMICS FC 500 WITH CXP