BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 11921446 · Received June 2, 2021

    Report

    Report Number
    2122870-2021-00074
    Event Type
    Injury
    Date Received
    June 2, 2021
    Date of Event
    May 24, 2021
    Report Date
    June 2, 2021
    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

    PATIENT IDENTIFIER: THE FULL PATIENT IDENTIFIER IS (B)(6). SEX, WEIGHT, AND ETHNICITY: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. DEVICE EVALUATED BY MFR: A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED ON CUSTOMER'S SITE TO PERFORM INTERFERENCE TESTING. PATIENT SAMPLE WAS FIRST TESTED NEAT FOR THE ACCUTNI+3 ASSAY. THE LSS OBTAINED A HIGH ACCUTNI+3 RESULT. CUSTOMER'S RESULTS WERE THEREFORE CONFIRMED. AN INTERFERENCE TESTING, USING DIFFERENT BLOCKERS, WAS THEN CARRIED OUT. POLYMAK 33, HBR-1, GOAT, MOUSE AND BOVINE IGGS WHICH ARE ANIMAL DERIVED ANTIBODIES WERE TESTED AND BLOCKER RELATED TO ALKALINE PHOSPHATASE, 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 THE ACCESS ACCUTNI+3 FOR USE ON UNICEL DXI SYSTEMS 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." IN CONCLUSION, THE INVESTIGATION DEMONSTRATED THAT HETEROPHILE INTERFERENCE IS THE CAUSE OF THE FALSELY ELEVATED ACCUTNI+3 PATIENT RESULTS.

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE FALSE ELEVATED TROPONIN I (ACCESS ACCUTNI+3, PART NUMBER A98264 AND LOT NUMBER 922065) RESULTS FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE INITIAL ACCUTNI+3 PATIENT RESULT WAS >84 NG/ML (THE MYOCARDIAL INFARCTION (MI) CUTOFF IS 0.03 NG/ML) WHILE ECG (ELECTROCARDIOGRAM) RESULT WAS NORMAL AND OTHER CARDIAC ASSAYS (CK-MB, CK AND MYOGLOBIN) RESULTS WERE WITHIN THE NORMAL REFERENCE RANGES AND DISCORDANT WITH THE ACCUTNI+3 RESULTS OBTAINED. THE CUSTOMER RECENTRIFUGED THE SAMPLE AND RETESTED IT WITH THE SAME RESULT OF >84 NG/ML. THE INITIAL AND THE RECENTRIFUGED SAMPLE WERE ALSO TESTED WITH THE HSTNI ASSAY WITH EXPECTED NORMAL RESULTS (0.0089 NG/ML AND 0.0078 NG/ML) AND ON AN ALTERNATE METHODOLOGY (RADIOMETER) WITH ACCEPTABLE NORMAL RESULTS WHICH WERE ALSO DISCORDANT WITH THE ACCESS ACCUTNI+3 RESULTS (DATA NOT PROVIDED). THE CUSTOMER REPORTED THAT THE PATIENT SURGERY (CHOLECYSTECTOMY) WAS SUSPENDED AND DELAYED FOR ABOUT HALF A DAY DUE TO THE FALSE HIGH ACCUTNI+3 RESULTS. NO SYSTEM CHECK, NO QUALITY CONTROL AND NO CALIBRATION DATA WERE PROVIDED. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. A LABORATORY SOLUTION SPECIALIST WAS DISPATCHED TO THE CUSTOMER SITE AND PERFORMED INTERFERENCE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816326 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER A98264 922065 15099590209353

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other