BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    MDR report key: 15833764 · Received November 21, 2022

    Report

    Report Number
    2122870-2022-00054
    Event Type
    Injury
    Date Received
    November 21, 2022
    Date of Event
    November 6, 2022
    Report Date
    November 21, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FULL PATIENT IDENTIFIER IS CASE: (B)(4). DEVICE EVALUATED BY MFR: THE ACCESS HIGH SENSITIVITY TROPONIN I REAGENT WAS NOT RETURNED FOR EVALUATION. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. THE CTS [CUSTOMER TECHNICAL SUPPORT] ADVISED THE CUSTOMER TO RUN SYSTEM CHECK AND PRECISION TEST TO VERIFY HARDWARE. PRECISION RUN PASSED, ALTHOUGH ONLY 10 POINTS WERE COMPLETED DUE TO QNS [INSUFFICIENT SAMPLE]. THE SYSTEM CHECK FAILED DUE TO QNS ON THE WASH PORTION, ALL THE REST OF NUMBERS LOOKED GOOD HOWEVER. THE CTS GUIDED THE CUSTOMER TO CHECK THE INSTRUMENT SETTINGS AND FOUND THAT THE UTILITY ASSAY WAS DISABLED SINCE ON (B)(6) 2022. THE CTS GUIDED THE CUSTOMER TO ENABLE THE UTILITY ASSAY THAT IS PART OF ROUTINE MAINTENANCE AS IT CLEANS THE INTERIOR OF THE ASPIRATE AND DISPENSE PROBES. THE INSTRUMENT WAS LAST PRIMED AROUND 3:00 AM AND THE PATIENT WAS RUN AROUND 3:00 PM WITH NO OTHER SAMPLES RUN BEFORE. THE INSTRUMENT SAT IDLE FOR APPROXIMATELY TWELVE (12) HOURS PRIOR TO THE QUESTIONED RESULT BEING RUN. ALTHOUGH IT WAS FOUND THAT THE UTILITY ASSAY WAS DISABLED AND THE INSTRUMENT SAT IDLE FOR TWELVE HOURS PRIOR TO RUNNING THE ELEVATED SAMPLE, THERE IS INSUFFICIENT EVIDENCE TO SUGGEST A HARDWARE MALFUNCTION OCCURRED IN THIS EVENT. FURTHERMORE, THERE WAS NO INDICATION OF CARRYOVER AS THE CUSTOMER DID NOT REPORT OBTAINING HIGH HSTNI SAMPLE RESULTS PRIOR THE QUESTIONED RESULT. IN CONCLUSION, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE CUSTOMER REPORTED ONE NON-REPEATABLE FALSE HIGH TROPONIN I (ACCESS HIGH SENSITIVITY TROPONIN I, PART NUMBER: B52699, LOT NUMBER: 234332) PATIENT RESULT WAS GENERATED ON THE CUSTOMER¿S ACCESS 2 IMMUNOASSAY ANALYZER (PART NUMBER: 81600N, SERIAL NUMBER: (B)(4). ONE ERRONEOUSLY HIGH HSTNI RESULT OF 56.7 PG/ML WAS OBTAINED ON (B)(6) 2022 AT 3:30 PM, REPEATED AT 5.3 PG/ML AT 5:29 PM. A SECOND SAMPLE FROM THE PATIENT WAS TESTED AT 6:07 PM WITH A RESULT OF 4.6 PG/ML. THE PATIENT WAS ADMINISTERED NITROGLYCERIN AS A RESULT OF THE ERRONEOUS HIGH HSTNI RESULT OF 56.7 PG/ML OBTAINED ON (B)(6) 2022. THE CUSTOMER REPORTED THAT THE PATIENT ACTUALLY REPORTED FEELING BETTER AFTER THAT. NO ADDITIONAL IMPACT OR CHANGE TO PATIENT TREATMENT WAS REPORTED IN CONNECTION WITH THE EVENT. 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. CALIBRATION PASSED ON (B)(6) 2022 WITH REAGENT LOT: 234332 AND CALIBRATOR LOT: 233800. THE CTS [CUSTOMER TECHNICAL SUPPORT] ADVISED THE CUSTOMER TO RUN SYSTEM CHECK AND PRECISION TEST TO VERIFY HARDWARE. PRECISION RUN PASSED, ALTHOUGH ONLY 10 POINTS WERE COMPLETED DUE TO QNS [INSUFFICIENT SAMPLE]. THE SYSTEM CHECK FAILED DUE TO QNS ON THE WASH PORTION, ALL THE REST OF NUMBERS LOOKED GOOD HOWEVER. THE CTS GUIDED THE CUSTOMER TO CHECK THE INSTRUMENT SETTINGS AND FOUND THAT THE UTILITY ASSAY WAS DISABLED SINCE ON (B)(6) 2022. THE CTS GUIDED THE CUSTOMER TO ENABLE THE UTILITY ASSAY THAT IS PART OF ROUTINE MAINTENANCE AS IT CLEANS THE INTERIOR OF THE ASPIRATE AND DISPENSE PROBES. THE INSTRUMENT WAS LAST PRIMED AROUND 3:00 AM AND THE PATIENT WAS RUN AROUND 3:00 PM WITH NO OTHER SAMPLES RUN BEFORE. THE INSTRUMENT SAT IDLE FOR APPROXIMATELY TWELVE (12) HOURS PRIOR TO THE QUESTIONED RESULT BEING RUN. SAMPLES ARE COLLECTED ON LITHIUM HEPARIN SAMPLE TUBES WITH NO GEL BARRIER AND CENTRIFUGED ON STAT SPIN WITH RANGE 6840-7560 FOR 3 MINUTES. NO ISSUES WITH SAMPLE INTEGRITY WERE NOTED. NO FURTHER SAMPLE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796978 ACCESS HIGH SENSITIVITY TROPONIN I REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER B52669 234332

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other