BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    MDR report key: 16158060 · Received January 13, 2023

    Report

    Report Number
    2122870-2023-00057
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    December 22, 2022
    Report Date
    January 13, 2023
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590693183
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FULL PATIENT IDENTIFIER IS (B)(4). THE CUSTOMER DID NOT SUPPLY 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. ALL ASSAY AND SYSTEM VERIFICATIONS MET SPECIFICATIONS AT THE TIME OF THE EVENT. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES 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 RESULT. THE TUBE WAS IDENTIFIED AS A PARTIAL DRAW VOLUME. SHORT SAMPLES ARE KNOWN TO AFFECT IMMUNOASSAYS BY MODIFYING BLOOD TO ADDITIVE RATIO. THEREFORE, USE ERROR IS A CAUSE OF THIS EVENT. THE CUSTOMER DID NOT FOLLOW THE CLSI GUIDELINES FOR PREANALYTICAL SAMPLE HANDLING. PER CLSI [CLINICAL AND LABORATORY STANDARDS INSTITUTE] GUIDELINE-GP44-A4: PROCEDURES FOR THE HANDLING AND PROCESSING OF BLOOD SPECIMENS FOR COMMON LABORATORY TESTS 4TH EDITION, ¿IF LESS BLOOD THAN REQUIRED IS DRAWN, THE EXCESS AMOUNT OF ADDITIVE HAS THE POTENTIAL TO ADVERSELY AFFECT THE ACCURACY OF TEST RESULTS." CUSTOMER TECHNICAL SUPPORT DISCUSSED PREANALYTICAL FACTORS AND SAMPLE HANDLING WITH THE CUSTOMER. IN CONCLUSION, PREANALYTICAL SAMPLE HANDLING WILL BE IMPLICATED AS THE LIKELY CAUSE FOR THIS EVENT AS THE TUBE WAS INCOMPLETELY FILLED THEREFORE MODIFYING THE BLOOD TO ADDITIVE RATIO. THERE IS NO EVIDENCE TO REASONABLE SUGGEST AN INSTRUMENT MALFUNCTION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE CUSTOMER REPORTED ONE NON-REPEATABLE FALSE HIGH TROPONIN I (ACCESS HIGH SENSITIVITY TROPONIN I, PART NUMBER B52699, LOT NUMBER 234522) PATIENT RESULT WAS GENERATED ON THE CUSTOMER¿S DXI 800 ACCESS IMMUNOASSAY W/SPOT B ANALYZER (PART NUMBER A71456, SERIAL NUMBER (B)(4)). ONE ERRONEOUSLY HIGH HSTNI RESULT OF 268.21 PG/ML WAS OBTAINED ON (B)(6) 2022. THE RESULT WAS QUESTIONED BY THE PHYSICIAN WHEN THE RESULTS FROM THE SUBSEQUENT DRAW DID NOT MATCH. THE CUSTOMER DID NOT PROVIDE THE RESULT OF THE SECOND SAMPLE. THE CUSTOMER REPEATED THE INITIAL SAMPLE WITH A RESULT OF 4.70 PG/ML OBTAINED ON A SECOND ANALYZER (UNICEL DXI 600 SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT THE PATIENT WAS UNNECESSARILY ADMINISTERED HEPARIN DUE TO THE INITIAL ELEVATED RESULT. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. SYSTEM CHECK PASSED ON (B)(6) 2022. QC WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES AT THE TIME OF THE EVENT. TWO PASSING CALIBRATION CURVES WERE OBTAINED ON (B)(6) 2022 USING REAGENT LOT 234522 AND CALIBRATOR LOT 233800. THERE WERE NO HIGH SAMPLES NOR OVR (OVER THE RANGE) FLAGGED HSTNI SAMPLES RAN PRIOR TO THE QUESTIONED SAMPLE. THE CTS [CUSTOMER TECHNICAL SUPPORT] ADVISED THE CUSTOMER TO RUN SYSTEM CHECK AND PRECISION TEST TO VERIFY HARDWARE. THE CUSTOMER PERFORMED SYSTEM CHECK AND 15 REPLICATE PRECISION RUN WITH ACCEPTABLE RESULTS ON 04JAN2023. SAMPLE IS COLLECTED ON LITHIUM HEPARIN SAMPLE TUBE. THE CUSTOMER REPORTED THAT THE SAMPLE WAS CENTRIFUGED FOR 5 MINUTES AT 3000 RPM. THE CUSTOMER REPORTED THE INITIAL LITHIUM HEPARIN TUBE WAS HALF FULL. NO FURTHER SAMPLE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528081 ACCESS HIGH SENSITIVITY TROPONIN I REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER B52669 234522 15099590693183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other