BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2223209 · Received August 12, 2011

    Report

    Report Number
    2122870-2011-02804
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    August 23, 2008
    Report Date
    August 23, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE PERFORMED HIGH SENSITIVITY (HS) SYSTEM CHECK, SYSTEM CHECK, AND A 50 POINT PRECISION RUN WHICH ALL MET SPECIFICATIONS. THE FSE ALSO REPLACED THE ASPIRATE PROBE TUBING AS A PRECAUTION. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURE AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH THE FSE REPLACED THE ASPIRATE PROBE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS 1 OF 2 SEPARATE MDR REPORTS RELATED TO 5 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REF MDR NO: 2122870-2011-02897 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 THRU (B)(4), 2010 FOR ADD'L 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 PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LAB. THE PT SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Additional Manufacturer Narrative · 2

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE PERFORMED HIGH SENSITIVITY (HS) SYSTEM CHECK, SYSTEM CHECK, AND A 50 POINT PRECISION RUN WHICH ALL MET SPECIFICATIONS. THE FSE ALSO REPLACED THE ASPIRATE PROBE TUBING AS A PRECAUTION. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURE AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH THE FSE REPLACED THE ASPIRATE PROBE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS 1 OF 2 SEPARATE MDR REPORTS RELATED TO 5 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REF MDR NO: 2122870-2011-02897 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 THRU (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 2

    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 PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LAB. THE PT SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Additional Manufacturer Narrative · 3

    THE FIELD SERVICE ENGINEER (FSE) WAS ON SITE ON (B)(4) 2008 TO INVESTIGATE THE EVENT. THE FSE PERFORMED HIGH SENSITIVITY (HS) SYSTEM CHECK, SYSTEM CHECK, AND A 50 POINT PRECISION RUN WHICH ALL MET SPECIFICATIONS. THE FSE ALSO REPLACED THE ASPIRATE PROBE TUBING AS A PRECAUTION. THE FSE VERIFIED THE REPAIR PER ESTABLISHED PROCEDURE AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ALTHOUGH THE FSE REPLACED THE ASPIRATE PROBE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS EVENT. THIS IS 1 OF 2 SEPARATE MDR REPORTS RELATED TO 5 PT EVENTS ASSOCIATED WITH A SINGLE MALFUNCTION REPORT ON DIFFERENT DAYS. REF MDR NO: 2122870-2011-02897 FOR ALL RELATED EVENTS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4), 2008 THRU (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 3

    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 PTS. THE INITIAL ERRONEOUSLY ELEVATED RESULTS WERE REPORTED OUTSIDE THE LAB. THE PT SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THERE ARE NO REPORTS OF ANY ADVERSE PT CONSEQUENCE OR ANY MEDICAL INTERVENTION TO PREVENT OR PRECLUDE ANY ADVERSE PT EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR ACCESS ACCUTNI
    2 90 YR ACCESS ACCUTNI
    3 63 YR ACCESS ACCUTNI