BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HSTNI

    MDR report key: 22491619 · Received July 14, 2025

    Report

    Report Number
    2122870-2025-00087
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 14, 2025
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    UDI-DI
    15099590693183
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE FULL IDENTIFIER FOR THIS REPORT IS (B)(4). A2, A3, A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. H3 AND H6: NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QC (QUALITY CONTROL) AT THE TIME OF THE EVENT WERE NOT PROVIDED FOR REVIEWING. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE QUESTIONED SAMPLE WAS SENT TO ANOTHER HOSPITAL FOR TESTING. THE SAMPLE WAS TESTED SIX DAY LATER WITH THE QUIDEL ORTHO METHODOLOGY WITH A HIGH HSTNI RESULT AT 0.019 NG/ML (REFERENCE RANGE: <0.016 NG/ML). THE ROCHE HSTNT RESULT WAS NORMAL AT 0.009 NG/ML (REFERENCE RANGE: <0.014NG/ML). THE PATIENT WENT TO ANOTHER HOSPITAL AND A NEW SAMPLE WAS COLLECTED AND THE ROCHE HSTNT RESULT WAS NORMAL AT 0.08 NG/ML (REFERENCE RANGE: <0.014NG/ML). THE LSS ASSISTED THE CUSTOMER TO COMMUNICATE WITH THE PATIENT, PER THE ACCESS HSTNI INSTRUCTIONS FOR USE (IFU), DOCUMENT PART NUMBER C18722 G AVAILABLE ON THE BECKMAN COULTER WEBSITE:" IN MYOCARDIAL INFARCTION, CTNI LEVELS RISE IN THE HOURS AFTER THE ONSET OF CARDIAC SYMPTOMS, REACHING A PEAK AT 12¿16 HOURS AND CAN REMAIN ELEVATED FOR 4¿9 DAYS POST MI. NUMEROUS PATHOLOGIES CAN POTENTIALLY CAUSE TROPONIN ELEVATIONS WITHOUT OVERT ISCHEMIC HEART DISEASE. THESE PATHOLOGIES INCLUDE, BUT ARE NOT LIMITED TO, CONGESTIVE HEART FAILURE, ACUTE AND CHRONIC TRAUMA, ELECTRICAL CARDIOVERSION, HYPERTENSION, HYPOTENSION, ARRHYTHMIAS, PULMONARY EMBOLISM, SEVERE ASTHMA, SEPSIS, CRITICAL ILLNESS, MYOCARDITIS, STROKE, NON¿CARDIAC SURGERY, EXTREME EXERCISE, DRUG TOXICITY (ADRIAMYCIN, 5¿FLUOROURACIL, HERCEPTIN, SNAKE VENOMS), END STAGE RENAL DISEASE, AND RHABDOMYOLYSIS WITH CARDIAC INJURY. IMPORTANTLY, THESE OTHER ETIOLOGIES RARELY DEMONSTRATE THE CLASSIC RISING AND FALLING PATTERN EXPERIENCED WITH A MI, WHICH HIGHLIGHTS THE IMPORTANCE OF SERIAL MONITORING WHEN THE CLINICAL SCENARIO IS UNCLEAR." AND "THE ACCESS HSTNI RESULTS SHOULD BE INTERPRETED IN LIGHT OF THE TOTAL CLINICAL PRESENTATION OF THE PATIENT, INCLUDING: SYMPTOMS, CLINICAL HISTORY, DATA FROM ADDITIONAL TESTS, AND OTHER APPROPRIATE INFORMATION." THE LSS CONFIRMED BY EMAIL THAT THE PATIENT WAS NOT DIAGNOSED WITH MYOCARDITIS. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED OBTAINING ONE FALSE HIGH ACCESS HSTNI (ACCESS HIGH SENSITIVITY TROPONIN I, PART NUMBER B52699, LOT NUMBER 440057) PATIENT RESULT ON THEIR DXI 800 ANALYZER (SERIAL NUMBER (SN) (B)(6)). ON (B)(6) 2025, THE HSTNI PATIENT RESULT WAS 0.6 NG/ML (CUSTOMER EXPECTED VALUE: <0.016 NG/ML). THE PATIENT HAD A CORONARY ANGIOGRAPHY PERFORMED DUE TO THE ELEVATED ACCESS HSTNI RESULT AND NO MYOCARDIAL INFARCTION WAS FOUND. ON (B)(6) 2025, THIS SAMPLE WAS RETESTED WITH A RESULT OF 0.260 NG/ML. PER CUSTOMER VERBAL REPORT, THE SAMPLE SHOWED DEGRADATION, BUT THE RESULT WAS STILL HIGH. NO HARDWARE ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QC (QUALITY CONTROL) AT THE TIME OF THE EVENT WERE NOT PROVIDED FOR REVIEWING. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. THERE WAS NO EVIDENCE TO SUGGEST CARRYOVER AS THE CUSTOMER DID NOT REPORT RUNNING A SAMPLE OF HIGH TROPONIN CONCENTRATION PRIOR TO THE QUESTIONED RESULT. A BECKMAN COULTER LSS (LABORATORY SOLUTION SPECIALIST) WAS DISPATCHED TO CUSTOMER SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774513 ACCESS HSTNI IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER, INC. 440057 15099590693183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other