BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    MDR report key: 16282404 · Received February 2, 2023

    Report

    Report Number
    2122870-2023-00059
    Event Type
    Injury
    Date Received
    February 2, 2023
    Date of Event
    January 18, 2023
    Report Date
    February 2, 2023
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590693183
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FULL PATIENT IDENTIFIER IS (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, GENDER, WEIGHT, ETHNICITY OR RACE. THE ACCESS HSTNI REAGENT WAS NOT RETURNED FOR EVALUATION. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. THERE WERE NO REPORTS OF HARDWARE ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS IN CONNECTION WITH THE EVENT. THERE WERE NO REPORTS OF ADDITIONAL ERRONEOUS RESULTS GENERATED ON THE DXI SERIAL NUMBER (B)(4) IN CONNECTION WITH THE EVENT. THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) DISPATCHED TO THE SITE FOUND NO HARDWARE ISSUES. FSE VERIFIED ALL ALIGNMENTS, PERFORMED A PASSING 10-POINT PRECISION TEST ON BOTH PIPETTORS AND RAN A PASSING SYSTEM CHECK. IN CONCLUSION, ALTHOUGH THE CUSTOMER STATED THAT THEY BELIEVED THE EVENT WAS CAUSED BY A SAMPLE HANDLING ISSUE, THERE IS INSUFFICIENT INFORMATION TO REASONABLY CONCLUDE THIS; THE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2023 THE CUSTOMER REPORTED AN ERRONEOUS NON-REPRODUCIBLE ELEVATED HSTNI (ACCESS HIGH SENSITIVITY TROPONIN I, PART NUMBER B52699 AND LOT NUMBER 234029) WAS GENERATED ON THE CUSTOMER'S DXI (DXI 600 ACCESS IMMUNOASSAY ANALYZER WITH SPOT B, PART NUMBER A71460 AND SERIAL NUMBER (B)(4) FOR ONE PATIENT. THE HSTNI RESULT OF 303.1 PG/ML WAS RELEASED FROM THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT MANAGEMENT IN ASSOCIATION WITH THE EVENT. THE CUSTOMER REPORTED THE PATIENT WAS TRANSFERRED TO AN ALTERNATE HOSPITAL AND UNDERWENT A CARDIAC CATHETERIZATION. THE CUSTOMER DID NOT PROVIDE FURTHER INFORMATION REGARDING CHANGE TO PATIENT TREATMENT OR MANAGEMENT. A 3-HOUR SAMPLE HAD BEEN COLLECTED FROM THE PATIENT; WHEN TESTED FOR HSTNI THE RESULT FOR THE 3 HOUR SAMPLE DRAW WAS <3 PG/ML. THE ORIGINAL SAMPLE WAS THEN RETESTED AND A RESULT OF <3 PG/ML WAS OBTAINED. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL (QC) WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WERE NO ERROR MESSAGES, ISSUES WITH OTHER ASSAYS OR ISSUES WITH OTHER SAMPLES REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT SAMPLES WERE QUESTIONED AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT COMPLAIN OF ANY POTENTIAL CONCERN OF CARRYOVER IN THIS EVENT. THE SAMPLE CONTAINER WAS COLLECTED IN THE EMERGENCY DEPARTMENT (ED) BY ED STAFF. SAMPLE WAS COLLECTED IN A 13X75 LITHIUM HEPARIN TUBE. SAMPLE HAD NO VISUAL ISSUES AND APPEARED TO BE A FULL TUBE. SAMPLE WAS TRANSFERRED TO THE LABORATORY WHERE IT WAS PLACED ON THE AUTOMATION LINE AND ALL HANDLING OF THE SAMPLE AT THAT POINT WAS WITH THE AUTOMATION LINE. AUTOMATION LINE DETAILS REGARDING CENTRIFUGATION AND OTHER SAMPLE HANDLING INFORMATION WAS NOT PROVIDED. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS SYSTEM PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901607 ACCESS HIGH SENSITIVITY TROPONIN I REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER B52669 234029 15099590693183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other