BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 11759910 · Received May 3, 2021

    Report

    Report Number
    2122870-2021-00059
    Event Type
    Injury
    Date Received
    May 3, 2021
    Date of Event
    April 8, 2021
    Report Date
    July 23, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    MMI
    UDI-DI
    15099590209353
    PMA / PMN Number
    K121214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE INTERNAL TNIDX NRFP INVESTIGATION, THE PRECIPITANT FOUND IN THE CONJUGATE WELL OF THE ACCUTNI+3 DXI REAGENT LOT 922911/922912 CORRELATES WITH THE NON-REPRODUCIBLE FLIERS OBSERVED AT SOME CUSTOMER SITES. THIS ISSUE WAS NOT CONSISTENTLY REPRODUCIBLE ON DXI INSTRUMENTS EVALUATED DURING THIS INVESTIGATION. OVER 20 DXI INSTRUMENTS WERE SCREENED USING A STANDARD PROTOCOL AND ONLY 1 INSTRUMENT WAS FOUND TO REPRODUCE THE ISSUE. ADDITIONALLY, THE AMOUNT OF PRECIPITANT IN THE CONJUGATE WELL VARIED AMONG REAGENT PACKS LOT 922911/922912. ALTHOUGH PRECIPITANT WAS IDENTIFIED IN THE CONJUGATE WELLS OF ALTERNATE LOTS OF ACCUTNI+3 DXI, THERE WERE NO NOTED INCREASE IN FLIER RATES. IN CONCLUSION, THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THERE IS NO EVIDENCE TO SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT. ALTHOUGH HARDWARE INTERVENTION WAS PERFORMED AND PRECIPITANT MAY HAVE CONTRIBUTED TO THIS ISSUE, THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(6). THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, SEX, WEIGHT, ETHNICITY OR RACE. THE ACCESS ACCUTNI+3 REAGENT WAS NOT RETURNED FOR EVALUATION. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE ON (B)(6) 2021 AND ADJUSTED ULTRASONICS. HE RAN 100 REPETITIONS OF TROPONIN USING WASH BUFFER AS SAMPLE AND DID NOT OBTAIN ANY FLYER. ANOTHER FSE WENT TO THE CUSTOMER SITE ON (B)(6) 2021 TO OBSERVE PRE-ANALYTICAL SPECIMEN HANDLING. HE INDICATED THAT NO PRE-ANALYTICAL ISSUE WAS SEEN WITH NO FIBRIN OR CELLULAR DEBRIS WITHIN SAMPLES. THE CUSTOMER IS RUNNING ALL ACCUTNI+3 PATIENT SAMPLES IN DUPLICATE AND IS INVESTIGATING ANY DISCREPANCIES. IN CONCLUSION, ALTHOUGH THE FSE SERVICED THE INSTRUMENT, THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING FALSE NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) RESULT FOR ONE PATIENT INVOLVING THE LABORATORY'S DXI 800 ACCESS IMMUNOASSAY W/SPOT B ANALYZER (SERIAL NUMBER (B)(4)). DESPITE MULTIPLE ATTEMPT HAVE BEEN MADE TO GET ADDITIONAL INFORMATION ON PATIENT RESULTS, NO ADDITIONAL INFORMATION WAS PROVIDED. ONE PATIENT WAS SENT TO THE CATHETERIZATION LABORATORY BUT, DESPITE MULTIPLE ATTEMPT, IT IS UNKNOWN IF THE PATIENT HAS BEEN CATHETERIZED OR NOT. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. CALIBRATION PASSED ON (B)(6) 2021 WITH REAGENT LOT 922912 AND CALIBRATOR LOT 922646. QUALITY CONTROL (QC) WAS PASSING WITHIN THE LABORATORYS ESTABLISHED RANGES. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER ON (B)(6) 2021 AND ADJUSTED ULTRASONICS. HE RAN 100 REPETITIONS OF TROPONIN USING WASH BUFFER AS SAMPLE AND DID NOT OBTAIN ANY FLYER. ANOTHER FSE WENT TO THE CUSTOMER SITE ON (B)(6) 2021 TO OBSERVE PRE-ANALYTICAL SPECIMEN HANDLING. HE INDICATED THAT NO PRE-ANALYTICAL ISSUE WAS SEEN WITH NO FIBRIN OR CELLULAR DEBRIS WITHIN SAMPLES. THE CUSTOMER IS RUNNING ALL ACCUTNI+3 PATIENT SAMPLES IN DUPLICATE AND IS INVESTIGATING ANY DISCREPANCIES. SAMPLE INFORMATION SUCH AS SAMPLE COLLECTION TUBE USED, CENTRIFUGATION TIME AND SPEED, STORAGE OR HANDLING WAS NOT PROVIDED BY THE CUSTOMER. THERE WAS NO REPORT OF SAMPLE INTEGRITY ISSUES. NO FURTHER SAMPLE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660909 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER A98264 922912 15099590209353

    Patients

    Seq Age Sex Outcome Treatment
    1 Other