BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 10670168 · Received October 13, 2020

    Report

    Report Number
    2122870-2020-00087
    Event Type
    Injury
    Date Received
    October 13, 2020
    Date of Event
    October 2, 2020
    Report Date
    October 13, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590209353
    PMA / PMN Number
    K121214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL PATIENT IDENTIFIER IS CASE-(B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. ACCESS ACCUTNI+3 REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. A BECKMAN LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO THE CUSTOMER SITE. THE LSS FIRST TESTED THE PATIENT SAMPLE NEAT FOR THE ACCUTNI+3 ASSAY AND OBTAINED A SIMILAR HIGH RESULT AT 25.56 NG/ML. AN INTERFERENCE TESTING, USING DIFFERENT BLOCKERS, WAS THEN CARRIED OUT. THE BLOCKERS USED IN THE INTERFERENCE TESTING CONSIST OF POLYMAK 33, HBR-1, GOAT, MOUSE AND BOVINE IGGS WHICH ARE ANIMAL DERIVED ANTIBODIES. A POOL OF BLOCKERS RELATED TO ALKALINE PHOSPHATASE (SCAV-ALP + AP MUTEIN POOL), WAS ALSO TESTED. INTERFERENCE ANTIBODIES INTERACTION ARE LISTED IN THE LIMITATIONS SECTION OF THE ACCUTNI+3 INSTRUCTIONS FOR USE. THIS INTERFERENCE TESTING DEMONSTRATED THE PRESENCE OF INTERFERING SUBSTANCES SINCE THE ADDITION OF HBR-1 BLOCKER SIGNIFICANTLY LOWERED THE SIGNAL. PER ACCESS ACCUTNI+3 INSTRUCTIONS FOR USE, ¿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.¿ IN CONCLUSION, THE INVESTIGATION DEMONSTRATED THAT HETEROPHILE INTERFERENCE IS THE CAUSE OF THE FALSELY ELEVATED ACCUTNI+3 RESULTS.

    Description of Event or Problem · 1

    ON (B)(6) 2020 THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE ERRONEOUSLY HIGH TROPONIN I (ACCESS ACCUTNI+3) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2020, ONE ACCUTNI+3 PATIENT SAMPLE RESULT WAS 29.48 NG/ML WHICH WAS ABOVE THE CUSTOMER'S REFERENCE RANGE (0-0.03 NG/ML). THE REPEAT RESULT WAS STILL HIGH AT 29.72 NG/ML. A CORONARY ANGIOGRAPHY WAS THEN PERFORMED DUE TO THE ELEVATED ACCESS ACCUTNI+3 RESULT, WHICH WAS NORMAL. THE SAMPLE WAS ALSO TESTED WITH THE ROCHE TNT ASSAY (0.006 NG/ML) AND THE XINGTONG MEDICAL TECHNOLOGY WITH BOTH NORMAL RESULTS (NO FURTHER INFORMATION PROVIDED). ON (B)(6) 2020 THE SAMPLE WAS ALSO TESTED WITH THE ACCESS HSTNI ASSAY. THE RESULT WAS NORMAL AT 4.095 PG/ML. A CORONARY ANGIOGRAPHY WAS PERFORMED DUE TO THE ELEVATED ACCESS ACCUTNI+3 RESULTS. THERE WAS NO ADDITIONAL CHANGE TO OR IMPACT TO PATIENT CARE REPORTED IN ASSOCIATION WITH THIS INCIDENT. ON (B)(6) 2020, A BECKMAN LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO THE CUSTOMER SITE. THE LSS FIRST TESTED THE PATIENT SAMPLE NEAT FOR THE ACCUTNI+3 ASSAY AND OBTAINED A SIMILAR HIGH RESULT AT 25.56 NG/ML. AN INTERFERENCE TESTING, USING DIFFERENT BLOCKERS, WAS THEN CARRIED OUT. THE BLOCKERS USED IN THE INTERFERENCE TESTING CONSIST OF POLYMAK 33, HBR-1, GOAT, MOUSE AND BOVINE IGGS WHICH ARE ANIMAL DERIVED ANTIBODIES. A POOL OF BLOCKERS RELATED TO ALKALINE PHOSPHATASE (SCAV-ALP + AP MUTEIN POOL), WAS ALSO TESTED. INTERFERENCE ANTIBODIES INTERACTION ARE LISTED IN THE LIMITATIONS SECTION OF THE ACCUTNI+3 INSTRUCTIONS FOR USE. THIS INTERFERENCE TESTING DEMONSTRATED THE PRESENCE OF INTERFERING SUBSTANCES SINCE THE ADDITION OF HBR-1 BLOCKER SIGNIFICANTLY LOWERED THE SIGNAL. SAMPLE INFORMATION SUCH AS SAMPLE COLLECTION TUBE USED, CENTRIFUGATION TIME AND SPEED, STORAGE OR HANDLING WAS NOT PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138589 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER A98264 921411 15099590209353

    Patients

    Seq Age Sex Outcome Treatment
    1 Other