BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS HIGH SENSITIVITY TROPONIN I REAGENT

    MDR report key: 15318330 · Received August 30, 2022

    Report

    Report Number
    2122870-2022-00042
    Event Type
    Injury
    Date Received
    August 30, 2022
    Date of Event
    August 8, 2022
    Report Date
    August 30, 2022
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590693183
    PMA / PMN Number
    K172787
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FULL PATIENT IDENTIFIER IS (B)(6). 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. NO ERROR MESSAGES OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONNECTION WITH THE EVENT. THERE WAS NO INDICATION OF CARRYOVER AS THE CUSTOMER DID NOT REPORT OBTAINING HIGH HSTNI SAMPLE RESULTS PRIOR THE QUESTIONED RESULTS. THE RESULTS OBTAINED BEFORE THE QUESTIONED HIGH RESULTS WERE NOT PROVIDED AND WERE NOT QUESTIONED BY THE CUSTOMER. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK, CALIBRATION AND QUALITY CONTROL WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CUSTOMER'S SITE. THE FSE INSPECTED THE INSTRUMENT AND DID NOT FIND ANY INSTRUMENT MALFUNCTION. THE FSE RAN A PRECISION TEST, AND THE RESULTS WERE WITHIN EXPECTED PARAMETERS. THE SYSTEM WAS VERIFIED TO MEET PUBLISHED PERFORMANCE SPECIFICATIONS. THE SYSTEM IS CONSIDERED OPERATIONAL. 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 FOUR (4) NON-REPEATABLE FALSE HIGH TROPONIN I (ACCESS HIGH SENSITIVITY TROPONIN I, PART NUMBER B52699, LOT NUMBER 233837) PATIENT RESULTS WERE GENERATED ON THE CUSTOMER¿S DXI 800 ACCESS IMMUNOASSAY W/SPOT B ANALYZER (PART NUMBER A71456, SERIAL NUMBER (B)(4)). ONE PATIENT WAS ADMINISTERED HEPARIN AS A RESULT OF THE ERRONEOUS HIGH HSTNI RESULT OF 86 PG/ML OBTAINED (B)(6) 2022. THE HEPARIN WAS SUSPENDED AFTER A SECOND RESULT WAS NORMAL (4 PG/ML). 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. CALIBRATION PASSED (B)(6) 2022 USING REAGENT LOT 233837 AND CALIBRATOR LOT 125542. QC WAS PASSING WITHIN THE LABORATORY¿S ESTABLISHED RANGES. SYSTEM CHECK PASSED (B)(6) 2022. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO CUSTOMER'S SITE (B)(6) 2022. THE FSE INSPECTED THE INSTRUMENT AND DID NOT FIND ANY INSTRUMENT MALFUNCTION. SAMPLES ARE COLLECTED ON BD LITHIUM HEPARIN TUBES AND CENTRIFUGED FOR 7 MINUTES AT 3000 RPM AT ROOM TEMPERATURE. NO ISSUES WITH SAMPLE INTEGRITY WERE NOTED. NO FURTHER SAMPLE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148498 ACCESS HIGH SENSITIVITY TROPONIN I REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER B52669 233837 15099590693183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other