BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS ACCUTNI+3 REAGENT

    MDR report key: 12120321 · Received July 6, 2021

    Report

    Report Number
    2122870-2021-00096
    Event Type
    Injury
    Date Received
    July 6, 2021
    Date of Event
    June 18, 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
    GA, 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 PRECIPITANT MAY HAVE CONTRIBUTED TO THIS ISSUE, THERE IS NOT ENOUGH INFORMATION TO DETERMINE THE CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    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 ACCUTNI+3 REAGENT WAS NOT RETURNED FOR EVALUATION. ALL ASSAY AND SYSTEM VERIFICATIONS MET SPECIFICATIONS AT THE TIME OF THIS EVENT. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. THERE WAS NO REPORT OF HARDWARE PARTS REPLACED IN CONNECTION WITH THIS EVENT. PRECISION RUN PASSED ON BOTH INSTRUMENTS SERIAL NUMBER (B)(4) AND (B)(4). IN CONCLUSION, THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. THE AVAILABLE INFORMATION DOES NOT REASONABLY SUGGEST THAT THE SYSTEM HAS MALFUNCTIONED.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE FALSE HIGH TROPONIN I (ACCESS ACCUTNI+3, PART NUMBER A98264, LOT NUMBER 922912) RESULTS INVOLVING THE LABORATORY'S DXI 600 ACCESS IMMUNOASSAY W/DUAL GANTRY ANALYZERS (SERIAL NUMBER (B)(4) AND (B)(4)). CUSTOMER NOTED THAT THEY HAVE REPORTED ERRONEOUS RESULTS OUT OF THE LAB. NO DATA WAS PROVIDED. THE CUSTOMER REPORTED THAT ONE PATIENT TREATMENT WAS CHANGED AND THE PATIENT RECEIVED AN UNNECESSARY CATHETERIZATION. CUSTOMER COULD NOT PROVIDE ANY MORE SPECIFICS REGARDING PATIENT THAT WAS TREATED AND COULD NOT SPECIFY ON WHICH INSTRUMENT THE ERRONEOUS RESULTS OCCURRED FOR THIS PATIENT. NO FURTHER DETAILS WERE PROVIDED. PASSING SYSTEM CHECK WAS OBTAINED ON (B)(6) 2021 FOR BOTH INSTRUMENTS. CALIBRATION PASSED ON 05MAY2021 USING REAGENT LOT 922912 AND CALIBRATOR LOT 922452 FOR INSTRUMENT SERIAL NUMBER (B)(4). CALIBRATION WAS OBTAINED ON 30APR2021 USING REAGENT LOT 922912 AND CALIBRATOR LOT 922452 FOR INSTRUMENT SERIAL NUMBER (B)(4). PRECISION RUN WAS PERFORMED ON (B)(6) 2021 WITH NO ISSUES ON BOTH INSTRUMENTS. SAMPLE TUBE COLLECTION TYPE WAS A BD RAPID SEPARATOR TUBES SEIZE 13*100. THE CUSTOMER REPORTED THAT SAMPLE WAS CENTRIFUGED FOR 5 MINUTES AT 4000 RPM AND 6 MINUTES AT 4400 RPM AT ROOM TEMPERATURE. CUSTOMER NOTED THAT THEY HAVE FREQUENT ISSUES WITH DELAYED CLOTTING DUE TO PATIENTS BEING ON HEPARIN. NO FURTHER SAMPLE INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017009 ACCESS ACCUTNI+3 REAGENT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI BECKMAN COULTER A98264 922912 15099590209353

    Patients

    Seq Age Sex Outcome Treatment
    1 Other