BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS 2 IMMUNOASSAY ANALYZER

    MDR report key: 11715178 · Received April 23, 2021

    Report

    Report Number
    2122870-2021-00048
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590265380
    PMA / PMN Number
    K922823/A007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT'S PERFORMANCE. THE FSE OBSERVED THE VACUUM PUMP WAS RUNNING LOW AND REPLACED IT. AFTER REPAIR, THE FSE RAN CALIBRATION, QUALITY CONTROL, SYSTEM CHECK, HS SYSTEM CHECK, AND TROPONIN VALIDATION PROCEDURE WITH ACCEPTABLE RESULTS. IN CONCLUSION, THE LIKELY CAUSE OF THE EVENT IS A HARDWARE MALFUNCTION OF THE VACUUM PUMP. REPLACING IT RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE TROPONIN I (ACCESS ACCUTNI+3) PATIENT RESULTS INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). THE CUSTOMER REPORTED THAT ONE OF THE PATIENTS WAS ADMITTED AND RECEIVED CATHETERIZATION WITH NO STENT PLACED. THE INITIAL RESULT WAS 0.04 NG/ML AT 18:22. UPON REPEAT AT 23:03 THE ACCUTNI+3 RESULT WAS 0.02 NG/ML. CUSTOMER CONSIDERS ACCUTNI+3 RESULTS THAT ARE >=0.02 NG/ML TO BE HIGH. CUSTOMER HAVE CEASED USE OF THE INSTRUMENT AS THREE OTHER NON-REPRODUCIBLE ACCUTNI+3 RESULTS WERE REPORTED FOR THREE PATIENTS AT 18:17 (0.04 NG/ML REPEATED AT 0.01 NG/ML AT 23:02), AT 18:40 (0.06 NG/ML REPEATED AT 0.01 NG/ML AT 23:05) AND AT 19:06 (0.06 NG/ML REPEATED AT 0.01 NG/ML AT 23:05). NO CHANGE IN PATIENT TREATMENT WAS REPORTED FOR THESE THREE PATIENTS. CALIBRATION PASSED ON 27MAR2021 USING REAGENT LOT 922659 AND CALIBRATOR LOT 922645. QUALITY CONTROL WAS WITHIN ACCEPTABLE RANGE. SYSTEM CHECK PASSED ON 28MAR2021. NO OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON 30MAR2021. THE FSE OBSERVED THE VACUUM PUMP WAS RUNNING LOW AND REPLACED IT. AFTER REPAIR, THE FSE RAN CALIBRATION, QUALITY CONTROL, SYSTEM CHECK, HS SYSTEM CHECK, AND TROPONIN VALIDATION PROCEDURE WITH ACCEPTABLE RESULTS. SAMPLE TUBE COLLECTION TYPE WAS LITHIUM HEPARIN GEL TUBE. THE CUSTOMER REPORTED THAT THE SAMPLE WAS CENTRIFUGED FOR 5 MINUTES AT 4500 REVOLUTIONS PER MINUTE. THE TUBES ARE RUN EITHER DIRECTLY ON THE INSTRUMENT OR IN INSERT CUPS, DEPENDING ON THE OPERATOR. 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
    616210 ACCESS 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER ACCESS 2 IMMUNOASSAY ANALYZER 15099590265380

    Patients

    Seq Age Sex Outcome Treatment
    1 Other