BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    MDR report key: 15715585 · Received November 2, 2022

    Report

    Report Number
    2122870-2022-00049
    Event Type
    Injury
    Date Received
    November 2, 2022
    Date of Event
    October 12, 2022
    Report Date
    November 2, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FULL PATIENT IDENTIFIER IS: (B)(6). DEVICE EVALUATED BY MFR: THE CUSTOMER DID NOT RETURN THE HSTNI REAGENT FOR EVALUATION. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST THAT THE SYSTEM HAS MALFUNCTIONED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. THERE WAS NO INDICATION OF CARRYOVER AS THE CUSTOMER DID NOT REPORT OBTAINING HIGH HSTNI SAMPLE RESULTS PRIOR THE QUESTIONED RESULTS. SYSTEM PERFORMANCE INDICATORS 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 · 0

    ON (B)(6) 2022 THE CUSTOMER REPORTED THAT ON (B)(6) 2022 AN ERRONEOUS NON-REPRODUCIBLE ELEVATED TROPONIN I (ACCESS HIGH SENSITIVITY TROPONIN I, PART NUMBER B52699 AND LOT NUMBER 233971) WAS GENERATED FOR ONE (1) PATIENT ON THE CUSTOMER'S ACCESS 2 (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER 505066). THE ERRONEOUS ELEVATED TROPONIN I RESULT OF 42.3 NG/L WAS RELEASED FROM THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THIS EVENT. PATIENT RECEIVED MEDICATIONS (CLEXANE, STATIN, CLOPIDOGREL, ASPIRIN); NO ADDITIONAL DETAIL REGARDING DURATION OF THE TREATMENT WAS PROVIDED. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH. THE ORIGINAL SAMPLE WAS REPEAT TESTED IN DUPLICATE ON (B)(6) 2022 AND RESULTS OF 3.9 NG/L AND 4.0 NG/L WERE OBTAINED. THE SAMPLE WAS ALSO TESTED USING THE ABBBOTT I-STAT CTNI ASSAY AND A RESULT OF 0.00 UG/L WAS OBTAINED. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PATIENT RESULTS WERE CALLED INTO QUESTION. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CUSTOMER DID NOT NOTE ANY ISSUES OR CONCERNS WITH POTENTIAL CARRYOVER FOR THIS EVENT. SAMPLE WAS A SERUM SAMPLE COLLECTED IN A SERUM TUBE. SAMPLE WAS NOTED TO BE A FULL DRAW. SAMPLE WAS CENTRIFUGED FOR 10 MINUTES AT 3000G AT ROOM TEMPERATURE. CENTRIFUGED SAMPLE WAS NOTED TO BE CLEAR. NO OTHER SAMPLE HANDLING INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305188 ACCESS HIGH SENSITIVITY TROPONIN I REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER B52669 233971

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other