BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    MDR report key: 15363058 · Received September 6, 2022

    Report

    Report Number
    2122870-2022-00045
    Event Type
    Injury
    Date Received
    September 6, 2022
    Date of Event
    August 20, 2022
    Report Date
    September 6, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590693183
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER: THE FULL PATIENT IDENTIFIER IS (B)(4). AGE OR DATE OF BIRTH, SEX, WEIGHT, AND ETHNICITY: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. H3 AND H6: THE ACCESS HIGH SENSITIVITY TROPONIN I REAGENT WAS NOT RETURNED FOR EVALUATION. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. THERE WERE NO REPORTS OF HARDWARE INTERVENTIONS PERFORMED OR HARDWARE PARTS REPLACED. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. A PRECISION RUN WAS RUN AND RECOVERED AS EXPECTED. THERE WAS NO INDICATION OF CARRYOVER AS THE CUSTOMER DID NOT REPORT OBTAINING HIGH HSTNI SAMPLE RESULTS PRIOR THE QUESTIONED RESULTS. THE RESULTS OBTAINED BEFORE THE QUESTIONED HIGH RESULTS WERE NOT PROVIDED AND WERE NOT QUESTIONED BY THE CUSTOMER. IN CONCLUSION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    ON (B)(6) 2022 THE CUSTOMER REPORTED ERRONEOUS NON-REPRODUCIBLE ELEVATED TROPONIN I RESULT (ACCESS HIGH SENSITIVITY TROPONIN I, PART NUMBER B53699 AND LOT NUMBER 234029) WAS GENERATED ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(4)) FOR ONE PATIENT. THE ERRONEOUS ELEVATED TROPONIN I RESULT OF 251.7 NG/L WAS RELEASED FROM THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE PATIENT WAS ADMINISTERED A HEPARIN DRIP (CUSTOMER COULD NOT PROVIDE DOSAGE OF HEPARIN). THE CUSTOMER ALSO REPORTED THE PATIENT WAS TRANSFERRED TO A DIFFERENT FACILITY. NO FURTHER PATIENT INFORMATION WAS PROVIDED. THE PATIENT SAMPLE WAS RETESTED ON THE SAME AND ALTERNATE INSTRUMENTS; EACH REPEAT OF THE SAMPLE AS WELL AS NEW SAMPLE COLLECTED ALL PRODUCED RESULTS OF <0.2 NG/L. THERE WERE NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS REPORTED IN CONNECTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, QUALITY CONTROL (QC) AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. SAMPLE WAS COLLECTED IN A LITHIUM HEPARIN TUBE. SAMPLE VOLUME COLLECTION WAS NOT INDICATED AND IT IS NOT KNOWN WHETHER THE SAMPLE TUBE WAS COMPLETELY FILLED. SAMPLE WAS CENTRIFUGED AT 5200 RPM FOR 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2832206 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