BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2024507 · Received March 20, 2011

    Report

    Report Number
    2122870-2011-00728
    Event Type
    Injury
    Date Received
    March 20, 2011
    Date of Event
    November 28, 2007
    Report Date
    November 29, 2007
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN THE ER INTO BD PLASTIC GEL TUBE. SAMPLE TYPE IS LITHIUM HEPARIN PLASMA. SAMPLE DID NOT APPEAR LIPEMIC OR HEMOLYZED. DRAW VOLUME WAS ADEQUATE. CENTRIFUGATION WAS DONE AT >5, 000 RPM FOR 8 MINUTES. SAMPLE 1 WAS RE-SPUN AT 13, 000 RPM FOR 3 MINUTES PRIOR TO REPEAT ANALYSIS. DILUTION TESTING REPRODUCED VALUES. QC RESULTED IN RANGE PRIOR TO AND FOLLOWING THE EVENT. SYSTEM CHECKS WERE PERFORMED ON (B)(4) 2007, AND RESULTS MET SPECIFICATIONS. CUSTOMER PERFORMED CALIBRATION VERIFICATION FOR THE LOT NUMBER IN USE ON (B)(4) 2007. MATERIAL MET ACCEPTANCE CRITERIA. NO ERRORS WERE RECEIVED IN THE EVENT LOG NEAR THE TIMES OF SAMPLE COMPLETION. ALTHOUGH SERVICE MAID REPAIRS TO THE SYSTEM ON (B)(4) 2007, A CUSTOMER PRODUCT LINE SUPPORT (CPLS) RECEIVED AN ALIQUOT OF THE SAMPLE IN QUESTION AND FOUND THE ADDITION OF BLOCKERS SIGNIFICANTLY REDUCED THE SAMPLE VALUE TO 0.00NG/ML. HETEROPHILE INTERFERENCE HAS BEEN CONFIRMED AS THE ROOT CAUSE OF THIS EVENT. NOTE: THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS/OCCURRENCES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING DISCORDANT TROPONIN (ACCUTNI) RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE RESULTS WERE REPRODUCIBLE BY THE ACCESS 2 ANALYZER. SAMPLES FROM THE PATIENT WERE TESTED FOR TROPONIN VIA I-STAT AND WERE NEGATIVE. THE PATIENT WAS ADMITTED TO THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS® 2 IMMUNOASSAY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization