BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS 2 IMMUNOASSAY ANALYZER

    MDR report key: 25312784 · Received May 28, 2026

    Report

    Report Number
    2122870-2026-00019
    Event Type
    Injury
    Date Received
    May 28, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BECKMAN COULTER, INC
    Product Code
    JJE
    UDI-DI
    15099590265380
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE FULL PATIENT IDENTIFIER IS CASE (B)(6). A2, A4 AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. H3 AND H6: A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CUSTOMER SITE. ON (B)(6) 2026, THE FSE ARRIVED AT THE CUSTOMER¿S LABORATORY. THE FSE CONFIRMED THE ISSUE, PLACED THE INSTRUMENT CONDITION IN DOWN-STATUS, AND ORDERED PARTS FOR A RETURN VISIT. ON (B)(6) 2026, THE FSE NOTED THAT THE INSTRUMENT WAS FAILING FOR HIGH SENSITIVITY (HS) NOFOAM WITH 15 FLYERS OUT OF 50 REPS. THE FSE REPLACED PRECISION PUMP, AND BELT, HOWEVER THE ISSUE PERSISTED. ON (B)(6) 2026, THE FSE RETURNED TO THE CUSTOMER¿S LABORATORY AND OBSERVED THE FOLLOWING ISSUES: ELEVATED REACTION LIGHT UNITS (RLUS) ON THE SUBSTRATE PUMP, WASH BUFFER SPLASHING ON THE LUMINOMETER LENS, INCUBATOR TRACK COMPONENTS (BEARINGS/PULLEYS) NOT ROTATING SMOOTHLY, EXCESSIVE VIBRATION FROM THE VACUUM PUMP, AND THE WASH CAROUSEL BEING OUT OF TEMPERATURE. THE FSE CLEANED THE LUMINOMETER LENS, PERFORMED DECONTAMINATION ON THE SUBSTRATE PUMP, RESEATED THE WASH CAROUSEL HEATER CABLES, AND REPLACED THE FOLLOWING PARTS: ASSEMBLY TENSION BRKT OFFSET L. H. FS, ASSEMBLY TENSION BRKT OFFSET R. H. FS, FST SCREW SOC ADH, PULLEY INVERTED INC BELT, PULLEY DRIVE INC BELT, FST RETAINING RING, BRNG BALL .250ID X .50, WASH/NEPH PUMP ASSEMBLY, AND ASSEMBLY MIXER BELT TENSION. BEFORE LEAVING THE CUSTOMER¿S LABORATORY, THE FSE VERIFIED AS SYSTEM CHECK PASSED. NO FURTHER ISSUE WAS REPORTED BY THE CUSTOMER. IN CONCLUSION, THERE IS SUFFICIENT EVIDENCE PROVIDED TO REASONABLY SUGGEST A HARDWARE MALFUNCTION WAS THE LIKELY CAUSE OF THIS EVENT. DUE TO MULTIPLE INTERVENTIONS PERFORMED, A SPECIFIC PART CANNOT BE IDENTIFIED AS THE SOLE CONTRIBUTOR OF THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2026, THE CUSTOMER REPORTED INTERMITTENTLY ERRONEOUSLY ELEVATED HSTNI PATIENTS RESULTS ON THEIR ACCESS 2 INSTRUMENT (PART NUMBER 81600N, SERIAL NUMBER (B)(6)). THE CUSTOMER REPORTED THAT ONE (1) PATIENT SAMPLE WITH ERRONEOUS FALSE-POSITIVE TROPONIN RESULTS WAS RELEASED OUT OF THE LABORATORY AND RESULTED IN THE PATIENT BEING TREATED WITH A HEPARIN DRIP (IV). SIX HOURS LATER, THE RESULT WAS NEGATIVE, AND REPEAT TESTING ALSO PRODUCED A NEGATIVE RESULT. THERE WAS NO REPORT OF FURTHER HARM TO THE PATIENT AS A RESULT OF THE CHANGE IN TREATMENT. INITIAL HSTNI PATIENT RESULT AT 18:06 ON (B)(6) 2026 WITH A RESULT OF "377" (NO UNITS PROVIDED). PATIENT STARTED ON HEPARIN DRIP (IV) AT 19:34. SECOND TROPONIN DRAWN AT 20:00, TRIGGERED A DELTA FLAG. BOTH SAMPLES WERE RERUN. INITIAL SAMPLE RERUN WITH A RESULT AT "6.43". CORRECTED RESULT REPORTED AT 21:40. SECOND TROPONIN THEN RESULTED "9.02" AT 21:54. HEPARIN DRIP DISCONTINUED AT 00:05. DIAGNOSIS OF NON-ST ELEVATION (EKG WAS NORMAL) REMOVED DUE TO ¿CORRECTED RESULT¿. ¿ SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE NOT PROVIDED FOR REVIEW. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. THERE WAS NO EVIDENCE TO SUGGEST CARRYOVER AS THE CUSTOMER DID NOT REPORT RUNNING SAMPLE OF HIGH TROPONIN CONCENTRATION PRIOR TO THE QUESTIONED RESULT. ON (B)(6) 2026, A FIELD SERVICE ENGINEER (FSE) ARRIVED AT THE CUSTOMER¿S LABORATORY. THE FSE CONFIRMED THE ISSUE, PLACED THE INSTRUMENT CONDITION IN DOWN-STATUS, AND ORDERED PARTS FOR A RETURN VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524237 ACCESS 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC 15099590265380

    Patients

    Seq Age Sex Outcome Treatment
    1