BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 11472084 · Received March 12, 2021

    Report

    Report Number
    2122870-2021-00028
    Event Type
    Injury
    Date Received
    March 12, 2021
    Date of Event
    February 25, 2021
    Report Date
    March 12, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590209353
    PMA / PMN Number
    K121214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL PATIENT IDENTIFIER IS (B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS WEIGHT, ETHNICITY OR RACE. THE ACCESS ACCUTNI+3 REAGENT WAS NOT RETURNED FOR EVALUATION. ALL ASSAY AND SYSTEM VERIFICATIONS MET SPECIFICATIONS AT THE TIME OF THE EVENT. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. A LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED ON CUSTOMER SITE TO PERFORM INTERFERENCE TESTING. THE NEAT SAMPLE RESULT WAS ELEVATED AT 1.08 NG/ML WHICH WAS ACCORDANT WITH THE ELEVATED RESULT REPORTED BY CUSTOMER. HOWEVER THE CONTROL RESULT SHOWED A BIAS OVER 25% THAT INDICATED A MATRIX EFFECT WITHIN SAMPLE. THE INTERFERENCE TESTING RESULTS COULD NOT BE INTERPRETED DUE TO THE MATRIX EFFECT. PER THE ACCESS ACCUTNI+3 INSTRUCTIONS FOR USE PART NUMBER B00495 M, IT STATES: "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. 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." "THE ACCESS ACCUTNI+3 ASSAY IS NOT INTENDED TO BE USED IN ISOLATION. RESULTS SHOULD BE INTERPRETED IN CONJUNCTION WITH OTHER DIAGNOSTIC TESTS AND CLINICAL INFORMATION. WHEN SERIAL SAMPLES ARE OBTAINED AND TROPONIN IS CONSIDERED IN THE CLINICAL CONTEXT OF EACH PATIENT, ACUTE EVENTS SUCH AS MI MAY BE DISTINGUISHED FROM OTHER CONDITIONS CAUSING MYOCARDIAL INJURY." IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS MALFUNCTION AS ORIGINAL RESULT IS DISCORDANT WITH 2 OR MORE REPLICATE MEASUREMENTS OF THE SAME SPECIMEN ON OTHER DEVICES.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE ELEVATED TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ANALYZER IMMUNOASSAY (SERIAL NUMBER (B)(4)). ONE PATIENT WAS ADMITTED ON (B)(6) 2021 AND HAD NORMAL BLOOD PRESSURE ON ADMISSION BUT THE ELECTROCARDIOGRAM SHOWED HIGH VOLTAGE ON THE LEFT VENTRICULAR SURFACE. CUSTOMER REPORTED THAT THE TROPONIN RESULTS FOR THIS PATIENT USED TO BE BEYOND THE NORMAL REFERENCE RANGE (>0.04 NG/ML) BUT THE ACCUTNI+3 RESULTS HAD INCREASED. THE UNEXPECTED INITIAL PATIENT SAMPLE RESULTS REPORTED WERE 1.596 NG/ML AND 1.797 NG/ML. THE PATIENT WAS RETESTED ON (B)(6) 2021 WITH A RESULT OF 1.782 NG/ML AND ON (B)(6) 2021 WITH A RESULT OF 1.583 NG/ML. CUSTOMER RUN SAMPLE PATIENT ON DIFFERENT PLATFORMS. THE ACCESS ACCUTNI+3 RESULTS WERE DISCORDANT WITH THE ACCESS HSTNI RESULTS WITH A LOW RESULT OF 0.00 NG/ML ON (B)(6) 2021, WITH THE VIDAS METHODOLOGY WITH A LOW RESULT OF <0.01 NG/ML (DATA NOT PROVIDED) AND WITH THE ROCHE METHODOLOGY WITH A LOW RESULT OF <0.005 NG/ML (DATA NOT PROVIDED). THE CUSTOMER REPORTED DELAYED TREATMENT DUE TO THE ELEVATED ACCESS ACCUTNI+3 RESULTS. PATIENT WAS WAITING FOR THE SEVENTH INJECTION OF A PD-1 IMMUNOTHERAPY TREATMENT. NO FURTHER INFORMATION WAS PROVIDED. NO SYSTEM CHECK WAS PROVIDED. CALIBRATION PASSED ON (B)(6) 2021 WITH REAGENT LOT 922394 AND CALIBRATOR LOT 922311. QC WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. A LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED ONSITE TO PERFORM INTERFERENCE TESTING. SAMPLE TUBE COLLECTION TYPE WAS NOT PROVIDED. SAMPLE PROCESSING INFORMATION SUCH AS CENTRIFUGATION TIME, SPEED AND TEMPERATURE WERE NOT PROVIDED. THERE WAS NO REPORT OF SAMPLE INTEGRITY ISSUES. NO FURTHER SAMPLE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371974 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER A98264 922394 15099590209353

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other