BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2320955 · Received November 3, 2011

    Report

    Report Number
    2122870-2011-05170
    Event Type
    Malfunction
    Date Received
    November 3, 2011
    Date of Event
    September 26, 2011
    Report Date
    October 5, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHA
    PMA / PMN Number
    K980173
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO A DISCREPANT RESULT FOR BHCG ON ONE PATIENT'S SAMPLE, WHICH WAS GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER. THE DISCREPANT RESULT WAS NOT REPORTED OUT OF THE LABORATORY. DILUTION TESTING WAS PERFORMED AND RECOVERED NON-LINEARLY. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE CUSTOMER DID NOT RECEIVE NOTICE OF DEATH OR INJURY TO PATIENT REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT. PATIENT SAMPLE INFORMATION, QC DATA, OR SYSTEM CHECK DATA WERE NOT PROVIDED BY THE CUSTOMER. THE SAMPLE WAS SENT TO CUSTOMER PRODUCT LINE SUPPORT (CPLS) EAST FOR ADDITIONAL PENDING. CPLS CONCLUSION: CPLS REPEATED CUSTOMER'S RESULT ON NEAT SAMPLE. DILUTION TEST RESULTS ALLOWED TO DETECT INTERFERENCE SINCE THE TEST WAS NOT LINEAR. HETEROPHILE TESTING TENDED TO SHOW THE PRESENCE OF INTERFERING SUBSTANCES SINCE AT LEAST ONE OF THE HETEROPHILE BLOCKERS USED IN THE TEST SLIGHTLY LOWERED THE SIGNAL. THE CHROMATOGRAPHIC ANALYSIS SHOWED THAT ELUTION FRACTIONS CORRESPONDING TO MOLECULE (43 KDA) WERE TESTED ON THE ACCESS ASSAY AND WERE NOT FOUND REACTIVE FOR THCG CONFIRMING THE VERY LOW LEVEL OF THCG IN THIS SAMPLE. SAMPLE SENT FOR ALTERNATIVE TESTING (ROCHE) WAS FOUND NEGATIVE CONFIRMING OUR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE DHA BECKMAN COULTER INC. TOTAL BHCG REAGENT PACK 170067

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR