BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2161806 · Received July 8, 2011

    Report

    Report Number
    2122870-2011-02132
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    December 13, 2008
    Report Date
    December 14, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE BUT WAS CANCELLED ON (B)(4) 2008 BECAUSE THE CUSTOMER HAS A BCI TRAINED BIO MED ONSITE. THE BIO MED TECHNICIAN PERFORMED HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN PUBLISHED SPECIFICATIONS. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS FOUR OF FIVE SEPARATE MDR REPORTS RELATED TO FIVE PATIENT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. REFERENCE MDR NUMBERS: MDR 2122870-2011-02129, MDR 2122870-2011-02130, MDR 2122870-2011-02131, MDR 2122870-2011-02133 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6), 2008 THROUGH (B)(6), 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO ERRONEOUSLY ELEVATED ACCUTNI (TROPONIN I) RESULTS GENERATED ON THE ACCESS 2 IMMUNOASSAY SYSTEM FOR FIVE PATIENTS. THE PATIENT SAMPLES WERE RETESTED AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE ELEVATED ACCUTNI RESULTS. NO FURTHER INFORMATION IS AVAILABLE RELATING TO ANY FURTHER TREATMENT OR CARE. IT IS; THEREFORE, UNKNOWN IF ANY FURTHER TREATMENT OR CARE WAS PROVIDED AS A RESULT OF THE HOSPITALIZATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization ACCESS ACCUTNI