BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2121822 · Received May 20, 2011

    Report

    Report Number
    2122870-2011-01231
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    November 22, 2008
    Report Date
    November 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGN
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. FSE NOTED THAT THE INSTRUMENT HAS A PREVENTATIVE MAINTENANCE (PM) PERFORMED ON IT ON (B)(4) 2008. THE FSE NOTED THAT A SYSTEM CHECK, HIGH SENSITIVITY SYSTEM CHECK, AND PRECISION RUNS ALL PASSED WITHIN INSTRUMENT AND ASSAY SPECIFICATIONS. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED FROM THIS EVENT. THIS IS ONE OF EIGHT SEPARATE MDR REPORTS RELATED TO EIGHT PATIENTS EVENT ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS 2122870-2011-01154, 01156, 01157, 01227, 01228, 01229, 01230 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) ON (B)(6) 2008 REGRADING ELEVATED ACCUTNI (TROPONIN) RESULTS ON EIGHT DIFFERENT PATIENTS. RESULTS WERE GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER RE-RAN THE SAMPLES ON A DIFFERENT INSTRUMENT IN THE LAB AND ALL THE RESULTS WERE NEGATIVE. THE INITIAL ELEVATED ACCUTNI RESULTS WERE REPORTED OUTSIDE THE LABORATORY. ITS UNKNOWN IF THERE IS ANY REPORTS OF ANY ADVERSE PATIENT CONSEQUENCE OR CHANGE TO THE PATIENTS' TREATMENT. THERE ARE NO INDICATIONS OF ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PATIENT EVENT. THIS REPORT REFERS TO PATIENT NUMBER EIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS 2 IMMUNOASSAY SYSTEM CGN BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ACCESS ACCUTNI