BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    MDR report key: 18364987 · Received December 20, 2023

    Report

    Report Number
    2122870-2023-00098
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    December 2, 2023
    Report Date
    December 20, 2023
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590693183
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE FULL PATIENT IDENTIFIER IS (B)(6). H3 AND H6: THE ACCESS HIGH SENSITIVITY TROPONIN I REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT REPORT ANY ISSUE WITH THE SAMPLE INTEGRITY FROM THE PRIMARY TUBE. HOWEVER THE ALIQUOTED REPEATED SAMPLE WAS REPORTED TO BE FOGGY WITH FLOATERS INSIDE. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AT CUSTOMER¿S SITE ON 5DEC2023. THE FSE RECALIBRATED WITH A NEW LOT OF HSTNI FOR INSTRUMENT EVALUATION. QC WAS PERFORMED AND WAS WITHIN ACCEPTABLE LIMITS. ON 07DEC2023, THE FSE PERFORMED THE HS SYSTEM CHECK WHICH PASSED. HE PERFORMED 258 HSTNI PRECISION RUN USING SAMPLE DILUENT A. THIS IS A DIAGNOSTIC TEST TO STRESS THE HARDWARE PERFORMANCE ALONG WITH THE ASSAY. THE FSE RAN THIS BOTH THROUGH THE CTA, (~100 REPLICATES) AND DIRECTLY ON THE DXI 800 (~150 REPLICATES). ALL OF THE REPLICATES OF THE SAMPLE DILUENT A WERE BELOW THE LOQ (LIMIT OF QUANTIFICATION) OF THE ASSAY. THE FSE ALSO LOOKED AT THIS DIAGNOSTIC TO MAKE SURE IT IS <2X THE CALIBRATOR S0 RLU VALUE, WHICH ALL REPLICATES WERE. THERE WERE NO REPAIRS OR ADJUSTMENTS MADE TO THE INSTRUMENT. QC PASSED WITHIN SPECIFICATIONS. ON 08DEC2023, THE FSE PERFORMED A CTA CARRYOVER TESTING THAT PASSED. THEN HE RUN A 20 REPLICATES PRECISION STUDY THOUGH THE CTA WITH A LOW QC, THE MEAN WAS 16.37 NG/L, THE SD WAS 0.51 AND THE % CV WAS 3.1 WHICH IS WITHIN THE HSTNI ASSAY PRECISION CLAIM. ALL OF THIS DATA SUGGESTS THE HARDWARE AND ASSAY ARE PERFORMING WELL AT THIS TIME. IN CONCLUSION, THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION EVEN IF A PRE-ANALYTICAL ISSUE IS SUSPECTED. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 0

    ON 03DEC2023, THE CUSTOMER REPORTED ONE NON-REPEATABLE ERRONEOUSLY ELEVATED TROPONIN I (ACCESS HIGH SENSITIVITY TROPONIN I, LOT NUMBER 338535) PATIENT RESULT INVOLVING THE LABORATORY'S DXI 800 ACCESS IMMUNOASSAY W/DUAL GANTRY ANALYZER (SERIAL NUMBER (S/N) (B)(6). THE INITIAL HSTNI PATIENT RESULT WAS 829 NG/L FROM A PRIMARY TUBE AND LOADED THROUGH THE CLOSED TUBE ALIQUOTTER (CTA) ON (B)(6) 2023. A SECOND SAMPLE FROM THE SAME PATIENT WAS COLLECTED AND THE HSTNI RESULT WAS 6.5 NG/L. BOTH RESULTS WERE RELEASED OUT OF THE LABORATORY AND WERE QUESTIONED BY THE PHYSICIAN. THEN THE CUSTOMER REPEATED THE INITIAL SAMPLE THAT GAVE A RESULT AT 6.3 NG/L ON ANOTHER DXI 800 INSTRUMENT (S/N NOT PROVIDED). NO ORIGINAL DATA WAS PROVIDED. THE CUSTOMER ALSO RUN A PRECISION TEST ON THE ORIGINAL SAMPLE AND THE RESULTS WERE RESPECTIVELY 6.3 NG/L, 6.1 NG/L AND 6.4 NG/L. PER CUSTOMER STATEMENT, THERE WAS A CHANGE IN THE PATIENT¿S TREATMENT DUE TO THE INITIAL ELEVATED BECKMAN HSTNI RESULT. THE TREATMENT IS UNKNOWN. THE PATIENT¿S CLINICAL FILE WAS NOT PROVIDED. THE CUSTOMER DID NOT WANT TO PROVIDE FURTHER INFORMATION. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM CHECK PASSED ON 3DEC2023. CALIBRATION PASSED ON 3NOV2023 WITH REAGENT LOT 338535 AND CALIBRATOR LOT 338238. QC PASSED WITHIN THE LABORATORY¿S ESTABLISHED RANGES AT TIME OF THE EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. THERE WAS NO INDICATION OF CARRYOVER AS THE CUSTOMER DID NOT REPORT OBTAINING HIGH HSTNI SAMPLE RESULTS PRIOR THE QUESTIONED RESULT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AT CUSTOMER¿S SITE ON 5DEC2023. THE CUSTOMER DID NOT REPORT ANY ISSUE WITH THE SAMPLE INTEGRITY FROM THE PRIMARY TUBE. THE SAMPLE WAS COLLECTED ON A LITHIUM HEPARIN PLASMA TUBE, IT WAS NOT HEMOLYZED, ICTERIC OR LIPEMIC. THE SAMPLE WAS RAN FROM THE CAPPED PRIMARY TUBE AND LOADED THROUGH THE CLOSED TUBE ALIQUOTTER. THE ALIQUOTED SAMPLE WAS STORED IN A REFRIGERATOR AND RESPUN BEFORE BEING REPEATED IN A CUP. IT WAS REPORTED TO BE FOGGY WITH FLOATERS INSIDE. HOWEVER REPEATED RESULTS WERE REPRODUCIBLE AND NOT QUESTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957916 ACCESS HIGH SENSITIVITY TROPONIN I REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER 338535 15099590693183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other