BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2478838 · Received March 5, 2012

    Report

    Report Number
    2122870-2012-00622
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 10, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY, WITH INTERFERENCE ELIMINATING PROTEINS, CONFIRMED THE EXISTENCE OF A PATIENT SOURCE INTERFERENT FOR THE SAMPLES RECEIVED FROM THE CUSTOMER. THE INTERFERENCE LIKELY RELATES TO ALKALINE PHOSPHATASE. THIS INTERFERING COMPOUND CAUSES REPRODUCIBLE FALSE POSITIVE RESULTS BUT IS DISTINCT FROM HETEROPHILE ANTIBODIES.PRODUCT LABELING: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HUMAN ANTI-MOUSE ANTIBODIES (HAMA), THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) SERVICED THE UNIT ON (B)(4) 2012 AND PERFORMED A HIGH SENSITIVITY SYSTEM CHECK WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. THE PATIENT'S SAMPLES WERE COLLECTED IN BECTON DICKINSON (BD) LITHIUM HEPARIN GEL SEPARATOR TUBES AND NO ABNORMALITIES WERE OBSERVED. QUALITY CONTROL (QC) WAS WITHIN RANGES. THE CUSTOMER STATED THERE WERE NO ERROR MESSAGES OR FLAGS ASSOCIATED WITH THE EVENT. THE CUSTOMER CENTRIFUGED THE SAMPLES FOR 5 MINUTES AT 5,000 RPM (REVOLUTIONS PER MINUTE) AT ROOM TEMPERATURE. BECKMAN COULTER, INC. CUSTOMER ADVOCATE (CA) REVIEWED BOTH LEVELS OF THE CUSTOMER SUPPLIED TROPONIN I QUALITY CONTROL (QC) DATA DATED FROM (B)(6) 2012. ALL TROPONIN I QC VALUES FOR THE TWO LEVELS OF QC WERE WITHIN THE CUSTOMER'S ESTABLISHED RANGES. THE CUSTOMER ADVOCATE ALSO REVIEWED THE CUSTOMER SUPPLIED TROPONIN I CALIBRATION CURVE FROM (B)(6) 2012. THE CALIBRATION CURVE WAS ACCEPTED AS PASSING AND HAD ACCEPTABLE PERCENT COEFFICIENT OF VARIATION (CV). THE CUSTOMER SUPPLIED A ROUTINE SYSTEM CHECK THAT WAS PERFORMED PRIOR TO THE EVENT ON (B)(6) 2012 WHICH PASSED WITHIN INSTRUMENT SPECIFICATIONS. THE CUSTOMER STATED THERE WERE NO ERRORS POSTED TO THE EVENT LOG IN CONJUNCTION WITH THE RESULTS NOR WERE THERE ANY ISSUES WITH HARDWARE, MAINTENANCE OR OTHER PATIENT RESULTS. ALL RELATED MEDWATCH REPORTS ASSOCIATED WITH THIS EVENT: 2122870-2012-00517, 2122870-2012-00563, 2122870-2012-00564, 2122870-2012-00622.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REPRODUCIBLE ELEVATED TROPONIN I (ACCUTNI) RESULTS, ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) LIMIT, FOR ONE PATIENT INVOLVING ACCESS 2 IMMUNOASSAY SYSTEM. SUBSEQUENT SAMPLE TESTING ON AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM RECOVERED A LOWER RESULT WITHIN THE NORMAL REFERENCE INTERVAL. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY AND QUESTIONED AS THE RESULTS DID NOT CORRELATE WITH THE PATIENT'S CLINICAL PRESENTATION. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR ACCESS ACCUTNI