BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    MDR report key: 10462656 · Received August 27, 2020

    Report

    Report Number
    2122870-2020-00073
    Event Type
    Injury
    Date Received
    August 27, 2020
    Date of Event
    August 18, 2020
    Report Date
    August 27, 2020
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590693183
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FULL PATIENT IDENTIFIER FOR THIS CASE IS (B)(6). THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS HIGH SENSITIVITY TROPONIN I REAGENT WAS NOT RETURNED FOR EVALUATION. THE INFORMATION PROVIDED SUGGESTS THAT THE ACCESS HIGH SENSITIVITY TROPONIN I ASSAY EXHIBITED IMPRECISION; A MALFUNCTION, AS SAMPLE RESULTS CONSISTED OF THREE OR MORE REPLICATE MEASUREMENTS OF THE SAME SPECIMEN ON THE SAME DEVICE EXCEEDED THE IMPRECISION CLAIM FOR THE ACCESS HIGH SENSITIVITY TROPONIN I ASSAY. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. REVIEW OF SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL SHOWS THEY WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. IN CONCLUSION, THE CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2020 THE CUSTOMER REPORTED A NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS HIGH SENSITIVITY TROPONIN I, PART NUMBER B52699 AND LOT NUMBER 921805) RESULT HAD BEEN GENERATED ON THE CUSTOMER'S ACCESS 2 PORTION OF THEIR DXC 600I ANALYZER (PART NUMBER A25635 AND SERIAL NUMBER (B)(4)). THE CUSTOMER'S PATIENT RESULT WAS ABOVE THE NORMAL RANGE OF THE ASSAY. THE INITIAL ELEVATED ACCESS HIGH SENSITIVITY TROPONIN I RESULT OF 84.272 PG/ML ((B)(6) 2020, 6:31PM) WAS RELEASED FROM THE LABORATORY. THE PATIENT SAMPLE WAS RETESTED ON (B)(6) 2020 AT 1:09AM AND 1:45AM; LOWER RESULTS OF 9.576 PG/ML (1:09AM) AND 8.767 PG/ML (1:45AM) AND 8.635 PG/ML (2:33AM) WERE OBTAINED. THERE WAS A REPORT OF CHANGE TO PATIENT CARE OR TREATMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE PATIENT WAS ADMINISTERED AN ANTI-PLATELET MEDICATION, CLOPIDROGEL (DOSE NOT PROVIDED). THERE WAS NO REPORT OF ADDITIONAL INJURY TO THE PATIENT IN CONNECTION WITH THIS EVENT. THERE IS NO FURTHER REPORT OF ADDITIONAL INJURY OR CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN ASSOCIATION WITH THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. NO HARDWARE ISSUES OR OTHER ASSAY OR SYSTEM ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO SAMPLE INTEGRITY ISSUES WERE REPORTED BY THE CUSTOMER. THE SAMPLE WAS COLLECTED IN A RAPID SERUM TUBE AND WAS NOTED TO BE A CLEAR SAMPLE. SAMPLE PROCESSING INFORMATION SUCH AS CENTRIFUGATION OR STORAGE TEMPERATURE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925428 ACCESS HIGH SENSITIVITY TROPONIN I REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER B52669 921805 15099590693183

    Patients

    Seq Age Sex Outcome Treatment
    1 Other