BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS2 IMMUNOASSAY SYSTEM

    MDR report key: 4909377 · Received July 13, 2015

    Report

    Report Number
    2122870-2015-00430
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    June 19, 2015
    Report Date
    June 21, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DEMOGRAPHICS SUCH AS SEX, AGE, DATE OF BIRTH OR WEIGHT WERE NOT SUPPLIED BY THE CUSTOMER. THE CUSTOMER'S BIOMEDICAL ENGINEER (BME) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE BME FOUND AIR BUBBLES IN THE WASH PUMP. THE BME REPLACED THE WASH VALVE COMPONENTS SUCH AS THE STATOR, ROTOR AND SEAL. AFTER THE REPAIRS WERE COMPLETED ALL VERIFICATION TESTING PASSED WITHIN PUBLISHED PERFORMANCE SPECIFICATIONS. IN CONCLUSION, THE CAUSE OF THE NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULT IS DUE TO HARDWARE MALFUNCTION, ALTHOUGH NO ONE PART CAN BE IMPLICATED AS THE SOLE CONTRIBUTOR IN THIS EVENT. BECKMAN COULTER (BEC) INTERNAL PATIENT IDENTIFIER FOR THIS REPORT IS (B)(6). ALL MDRS ASSOCIATED WITH THIS EVENT: 2122870-2015-00427; 2122870-2015-00428; 2122870-2015-00429; 2122870-2015-00430; 2122870-2015-00431; 2122870-2015-00432.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ELEVATED, NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR SIX (6) PATIENTS IN ASSOCIATION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4). A NON-REPRODUCIBLE ACCESS ACCUTNI+3 RESULT WAS OBTAINED FOR THE FOURTH PATIENT (DESIGNATED AS PATIENT FOUR (4)). THE INITIAL ELEVATED ACCESS ACCUTNI+3 RESULT WAS RELEASED FROM THE LABORATORY AND THE PATIENT WAS TRANSFERRED TO AN ALTERNATE FACILITY. THE INITIAL SAMPLE (DESIGNATED AS SAMPLE ONE (1)) FROM PATIENT FOUR (4) WAS REANALYZED TWICE USING THE SAME ACCESS 2 IMMUNOASSAY SYSTEM, AND LOWER RESULTS, WITHIN THE LABORATORY'S NORMAL REFERENCE RANGE WERE OBTAINED. A SECOND SAMPLE (DESIGNATED AS SAMPLE TWO (2)) FROM PATIENT FOUR (4) WAS ANALYZED ONCE AT AN ALTERNATE FACILITY ON AN ALTERNATE ACCESS 2 IMMUNOASSAY SYSTEM AND TWICE USING THE SAME ACCESS2 IMMUNOASSAY SYSTEM, AND LOWER RESULTS, WITHIN THE ASSAY'S NORMAL REFERENCE RANGE WAS OBTAINED. THE CUSTOMER STATED TWO (2) OF THE SIX (6) PATIENTS WERE ADMINISTERED STRESS TESTS AND THE RESULTS WERE DETERMINED TO BE NEGATIVE. THE CUSTOMER WAS UNABLE TO IDENTIFY WHICH OF THE SIX PATIENTS RECEIVED A STRESS TEST. THERE WAS NO REPORT OF ADDITIONAL INJURY WHICH OCCURRED IN ASSOCIATION WITH THIS EVENT. THE FOLLOWING MDRS WILL ADDRESS THE NON-REPRODUCIBLE ACCESS ACCUTNI+3 RESULTS FOR THE ADDITIONAL FIVE (5) PATIENTS: 2122870-2015-00427, 2122870-2015-00428, 2122870-2015-00429, 2122870-2015-00431, AND 2122870-2015-00432. QUALITY CONTROL (QC), CALIBRATION, SYSTEM CHECK, AND PRECISION WERE PERFORMING WITHIN ASSAY AND INSTRUMENT SPECIFICATIONS. THE SAMPLE WAS COLLECTED IN A LITHIUM PLASMA SEPARATOR TUBE AND POURED OFF IN TO A ONE (1) ML INSERT CUP FOR TESTING. THE SAMPLE WAS CENTRIFUGED FOR THREE (3) MINUTES AT 7200 RPM (REVOLUTIONS PER MINUTE). NO SAMPLE INTEGRITY ISSUES WERE NOTED BY THE CUSTOMER. THE CUSTOMER'S BIOMEDICAL ENGINEER (BME) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454011 ACCESS2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O