BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I

    MDR report key: 12428596 · Received September 6, 2021

    Report

    Report Number
    2122870-2021-00132
    Event Type
    Injury
    Date Received
    September 6, 2021
    Date of Event
    July 23, 2021
    Report Date
    August 26, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590693183
    PMA / PMN Number
    K121214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FULL PATIENT IDENTIFIER IS (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, WEIGHT, ETHNICITY OR RACE. THE ACCESS HIGH SENSITIVITY TROPONIN I REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. IN CONCLUSION, THE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    ON 23AUGUST 2021 THE CUSTOMER REPORTED ERRONEOUS ELEVATED NON-REPRODUCIBLE HSTNI (ACCESS HIGH SENSITIVITY TROPONIN I, PART NUMBER B52699 AND LOT NUMBER 922713) WERE GENERATED FOR ONE PATIENT ON THE ACCESS 2 PORTION OF THE CUSTOMER¿S DXC 600I (PART NUMBER A25635 AND SERIAL NUMBER (B)(4)) ON (B)(6) 2021. INITIAL RESULT OBTAINED WAS 86.7 NG/L; REPEAT TESTING OF UNCENTRIFUGED SAMPLE ON (B)(6) 2021 PRODUCED RESULTS OF 7.0 NG/L AND 6.7 NG/L. SAMPLE WAS RECENTRIFUGED AND REPEAT TESTED IN DUPLICATE ON (B)(6) 2021; RESULTS OF 7.0 NG/L AND 7.0 NG/L WERE OBTAINED. SAMPLE WAS ALSO TESTED ON AN I-STAT DEVICE ON (B)(6) 2021; RESULT OF 0.01 UG/L WAS OBTAINED. THERE WAS A REPORT OF CHANGE TO PATIENT CARE OR MANAGEMENT IN CONNECTION WITH THIS EVENT. THE PATIENT WAS ADMINISTERED INTRAVENOUS (IV) HEPARIN. THE IV HEPARIN WAS STOPPED AFTER CUSTOMER REPEAT TESTED THE INITIAL SAMPLE AND OBTAINED LOWER HSTNI RESULTS. THERE WAS NO FURTHER REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT OR PATIENT INJURY ASSOCIATED WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS. NO OTHER PATIENT SAMPLE RESULTS WERE CALLED INTO QUESTION. SAMPLE WAS A SERUM, REPORTED TO BE A FULL DRAW. SAMPLE WAS NOTED TO BE CLEAR. SAMPLE WAS CENTRIFUGED AT 3000 G FOR 10 MINUTES. NO OTHER SAMPLE COLLECTION OR PROCESSING INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325025 ACCESS HIGH SENSITIVITY TROPONIN I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER B52669 922713 15099590693183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other