BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY SYSTEM

    MDR report key: 2172116 · Received June 15, 2011

    Report

    Report Number
    2122870-2011-01801
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    September 5, 2007
    Report Date
    October 29, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED MULTIPLE ERRORS WERE RECEIVED, INCLUDING THE REACTION VESSEL (RV) CLEANOUT ERROR. CUSTOMER TECHNICAL SUPPORT (CTS) RECOMMENDED THE USE OF PERSONAL PROTECTIVE EQUIPMENT (PPE) BEFORE TROUBLESHOOTING. CTS INFORMED THE CUSTOMER OF THE POTENTIAL BIOHAZARDS AND SAFETY HAZARDS ASSOCIATED WITH TROUBLESHOOTING WHICH MAY INCLUDE A POTENTIAL FOR SHOCK, PUNCTURE OR PINCH AND ADVISED THE CUSTOMER TO REMOVE JEWELRY AND USE PROPERLY INSTALLED TOOLS TO MINIMIZE RISKS. THE CUSTOMER UNDERSTOOD AND AGREED TO CONTINUE TROUBLESHOOTING. THE COVERS HAD ALREADY BEEN REMOVED. CTS GUIDED THE CUSTOMER THROUGH CLEANING OUT THE RV'S, HOMING THE SHUTTLE, RAKE, MOVING RAKE TO POSITION, HOMING THE INC. BELT AND INITIALIZING. THE CUSTOMER WAS ABLE TO RETURN TO READY MODE. CTS GUIDED THE CUSTOMER THROUGH REPLACING THE COVERS. THE UNIT WAS RETURNED TO OPERATION. SAMPLES WERE NOT AVAILABLE FOR ADD'L TESTING. CLINICAL HISTORY WAS NOT SUPPLIED. SAMPLE TYPES AND PROCESSING DETAILS WERE NOT SUPPLIED. SYSTEM CHECK RESULTS FROM (B)(4) 2007 ON SYSTEM (B)(4) WERE SUPPLIED AND INDICATED ALL RESULTS MET THE MFR'S SPECS. QUALITY CONTROL (QC) HISTORY WAS NOT SUPPLIED. THE CUSTOMER DID NOT PROVIDE WHICH SYSTEM THE RESULTS OCCURRED ON. FOR ASSAYS EMPLOYING MOUSE ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HUMAN ANTI-MOUSE ANTIBODIES (HAMA) IN THE SAMPLE. HUMAN ANTI-MOUSE ANTIBODIES MAY BE PRESENT IN SAMPLES FROM PTS WHO HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING MONOCLONAL ANTIBODIES OR IN INDIVIDUALS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES, SUCH AS HUMAN ANTI-GOAT ANTIBODIES, MAY BE PRESENT IN PT SAMPLES. IN ADDITION, ELEVATED TROPONIN-I LEVELS HAVE ALSO BEEN DOCUMENTED IN CASES IN OTHER CARDIAC CONDITIONS SUCH AS UNSTABLE ANGINA, CONGESTIVE HEART FAILURE, OR MYOCARDITIS, OR SEVERE NON-CARDIAC CONDITIONS SUCH AS TRAUMA OR RENAL FAILURE THAT MAY CAUSE CARDIAC MUSCLE INJURY. THUS TROPONIN (ACCUTNI) RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, CLINICAL EXAMINATION, ELECTROCARDIOGRAM (ECG), DATA FROM ADD'L TESTS, AND OTHER APPROPRIATE INFO. MED DECISIONS SHOULD NOT BE BASED ON A SINGLE ACCUTNI DETERMINATION AT ONE TIME POINT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 THROUGH (B)(4), 2010 FOR ADD'L REPORTABLE EVENTS. THIS MEDWATCH REPORT IS RELATED TO MDRS: 2122870-2011-01800, 01802, AND 01803.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED TROPONIN (ACCUTNI) PT RESULTS INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. THE CUSTOMER DID NOT KNOW WHICH ACCESS 2 IMMUNOASSAY SYSTEM THE RESULTS OCCURRED ON. THIS IS REPORT NUMBER TWO OF FOUR REFERENCING SYSTEM (B)(4). VALUES OBTAINED WERE ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF AND NEGATIVE VIA AN ALTERNATE METHODOLOGY. VALUES REMAINED ELEVATED WITH A NEW DRAW TWO MONTHS AFTER. THE CUSTOMER SUSPECTED HETEROPHILE INTERFERENCE BUT DID NOT PERFORM ADD'L TESTING, AND STATED THE RESULTS WERE ELEVATED AND REPRODUCIBLE. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LAB. THERE HAS BEEN NO REPORT OF PT INJURY OR CHANGE IN PT TREATMENT ASSOCIATED WITH THIS 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 43 YR ACCESS ACCUTNI