BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    MDR report key: 15789248 · Received November 14, 2022

    Report

    Report Number
    2122870-2022-00051
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    October 28, 2022
    Report Date
    November 14, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590693183
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FULL PATIENT IDENTIFIER IS (B)(4). 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 607216 IN CONNECTION WITH THE EVENT. REVIEW OF EVENT LOG WAS UNREMARKABLE AND DID NOT INDICATE ANY ISSUES. A TEN REPLICATE PRECISION STUDY WAS PERFORMED WITH A LOW QC LEVEL. THE %CV AT 6.37% WAS WITHIN THE PRECISION SPECIFICATIONS. THE CUSTOMER ALSO PERFORMED A CARRYOVER TEST AND IT PASSED ON (B)(6) 2022. IN CONCLUSION, THE CAUSE OF THIS INCIDENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. ALTHOUGH THE CUSTOMER SUSPECTED A CARRYOVER, THERE IS INSUFFICIENT INFORMATION TO CONFIRM THIS ISSUE. REPLACING THE REAGENT PACK LOT 234029 SERIAL NUMBER 1340 RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2022 THE CUSTOMER REPORTED THAT ON (B)(6) 2022 AN ERRONEOUS ELEVATED HDTNI RESULT (ACCESS HIGH SENSITIVITY TROPONIN I, PART NUMBER B52699 AND LOT NUMBER 234029) WAS GENERATED ON THE CUSTOMER'S DXI (DXI 800 IMMUNOASSAY ANALYZER, PART NUMBER 973100 AND SERIAL NUMBER (B)(4). THE CUSTOMER SUSPECTED A REAGENT PACK CONTAMINATION. PATIENT HSTNI VALUE WAS 1638 PG/ML THEN REPEATED AT <3 PG/ML ON (B)(6) 2022. THE HSTNI VALUES ABOVE WERE OBTAINED ON HSTNI REAGENT LOT 234029 SERIAL NUMBER (B)(4). THERE WAS NO REPORT OF AN INJURY OR ILLNESS TO THE PATIENT ATTRIBUTABLE TO THE OUTPUT FROM THE DEVICE IN THIS EVENT. THE PATIENT BEGAN TREATMENT FOR ACUTE CORONARY SYNDROME (ACS) AFTER THE ERRONEOUS ELEVATED HSTNI RESULT WAS OBTAINED. CUSTOMER STATED THE STANDARD TREATMENT PROVIDED INCLUDED FIVE STEPS: 1) 300 MG ASPIRIN; 2) FONDAPARINUX 2.5 MG (UNLESS PATIENT ON WARFARIN); 3) BISOPROLOL OR RAMIPRIL; 4) ATORVASTATIN AND 5) GLYCERYL TRINITRATE SPRAY PLUS MORPHINE. CUSTOMER STATED THEY BELIEVED PATIENT RECEIVED FIRST THREE STEPS OF TREATMENT BUT WAS UNABLE TO CONFIRM PATIENT RECEIVED ALL FIVE STEPS OF TREATMENT. THERE WERE NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS REPORTED IN CONJUNCTION WITH THIS INCIDENT. SYSTEM CHECK AND CALIBRATION WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE INCIDENT. QC PASSED ON (B)(6) 2022. ON (B)(6) 2022, THE QC LEVEL 1 RESULTS WERE OUTSIDE HIGH OF THE 3SD RANGES WITH REAGENT LOT 234029 SERIAL NUMBER (B)(4). THE QC LEVEL 2 VALUE WAS LOW VS TARGET VALUE, IT WAS RAN ON THE SAME REAGENT PACK LOT AND SERIAL NUMBER ON (B)(6) 2022. AFTER THIS LAST VALUE, THE REAGENT PACK 234029 SERIAL NUMBER (B)(4)WAS DISCARDED. THE CUSTOMER EXCLUDED A QC MATERIAL CONTAMINATION. THERE WERE NO REPORTS OF ISSUES WITH SAMPLE INTEGRITY. NO ISSUE WITH THE SAMPLE INTEGRITY WAS REPORTED. THE SAMPLES WERE COLLECTED ON LITHIUM HEPARIN TUBES, THEY STAND FOR 25 MINUTES AND THEY WERE CENTRIFUGED AT 3000 RPM FOR 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417549 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