BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2I (LXI) IMMUNOASSAY SYSTEM

    MDR report key: 1914247 · Received December 3, 2010

    Report

    Report Number
    2122870-2010-00852
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K023049
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN BD LITHIUM HEPARIN TUBES. QC WAS WITHIN SPECIFICATIONS. SERVICE WAS NOT DISPATCHED. A CLEAR ROOT CAUSE CAN NOT BE DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO NON-REPRODUCIBLE FALSE POSITIVE ACCUTNI RESULT FOR ONE PATIENT GENERATED BY ACCESS 2I (LXI) IMMUNOASSAY SYSTEM. THE CUSTOMER HAS A PROACTIVE PROCEDURE IMPLEMENTED TO VERIFY ALL UNEXPECTED RESULTS PRIOR TO REPORTING OUT OF THE LABORATORY. THE PRACTICE IS TO RETEST ALL ACCUTNI RESULTS OF >0.1 NG/ML THROUGH AN AUTOMATIC RERUN PROCESS. IF THE REPEAT DOES NOT MATCH AN ALIQUOT OF THE SAMPLE WILL BE RE-SPUN AND RE-TESTED. THE EVENT WILL BE ASSUMED TO BE A WORSE CASE SCENARIO AND INITIAL RESULT RECOVERED WAS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF. THE SAMPLE WAS REPEATED AND RESULT WITHIN THE NORMAL REFERENCE RANGE WAS OBTAINED. RAW DATA RESULTS WERE NOT PROVIDED. THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2I (LXI) IMMUNOASSAY SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER MMI BECKMAN COULTER INC. ACCESS2 LXI

    Patients

    Seq Age Sex Outcome Treatment
    1