BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXI 800 IMMUNOASSAY ANALYZER

    MDR report key: 21106190 · Received January 8, 2025

    Report

    Report Number
    2122870-2025-00049
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    November 27, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    UDI-DI
    15099590265373
    PMA / PMN Number
    K023764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1: THE FULL PATIENT IDENTIFIER IS (B)(4). A2, A3, A4, AND A5: THE CUSTOMER DID NOT SUPPLY PATIENT DEMOGRAPHICS SUCH AS AGE, DATE OF BIRTH, GENDER, WEIGHT, ETHNICITY OR RACE. H3 AND H6: NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. ON (B)(6) 2025 THE GLOBAL PRODUCT TECHNICAL SUPPORT WAS CONTACTED AND STATED AS QUALITY CONTROL (QC), CALIBRATIONS AND SURVEY SAMPLES DID NOT DEMONSTRATE ANY ISSUE, THE ASSAYS PERFORMED AS INTENDED. THERE WERE NO FURTHER ISSUES REPORTED FROM THE CUSTOMER. IN CONCLUSION, THE EXACT CASE FOR THIS EVENT CANNOT BE DETERMINED WITH THE INFORMATION AVAILABLE. THERE IS INSUFFICIENT EVIDENCE TO REASONABLY SUGGEST THAT A MALFUNCTION OCCURRED IN CONJUNCTION WITH THIS EVENT.

    Description of Event or Problem · 0

    ON 11DEC2024 THE CUSTOMER REPORTED QUESTIONED THYROID PARAMETER (ACCESS FREE T3 PART NUMBER A13422 LOT NUMBER 472174, ACCESS FREE T4 PART NUMBER 33880 LOT NUMBER 472176, AND ACCESS TSH3 (THYROID STIMULATING HORMONE) PART NUMBER B63284 LOT NUMBER 472145) RESULTS FOR 10 PATIENTS, AND THE RESULTS WERE INCONSISTENT WITH THE ABBOTT METHOD (EXACT METHODOLOGY UNKNOWN). THE RESULTS WERE GENERATED ON THE CUSTOMER'S UNICEL DXI 800 IMMUNOASSAY ANALYZER, (PART NUMBER 973100, SERIAL NUMBER (B)(6)). THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN DIAGNOSIS AND/OR TREATMENT DUE TO THE IMPRECISE RESULTS. THE EXACT NUMBER OF PATIENTS WHO WERE AFFECTED BY A DELAY WAS NOT REPORTED TO BECKMAN AND IS UNKNOWN. UPON ADDITIONAL FOLLOW-UP WITH THE BECKMAN LOCAL SUPPORT TEAM, THE INFORMATION REGARDING THE DELAY WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER CONFIRMED THE DOCTOR CHANGED ONE PATIENT'S DIAGNOSIS FROM HYPOTHYROIDISM TO HYPERTHYROIDISM WHEN THE TEST WAS REPEATED, HOWEVER THEY CONFIRMED THE PATIENT HAD NOT BEEN PLACED ON ANY MEDICATIONS. THE SAMPLES WERE SENT TO AN ALTERNATE LABORATORY, USING AN ABBOTT METHODOLOGY, AND THE RESULTS ARE BELIEVED TO BE MORE IN LINE WITH THE PATIENTS' CLINICAL FILE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER. THERE WAS A RIQAS SURVEY RUN ON (B)(6) 2024 WITH PASSING RESULTS AND DID NOT DEMONSTRATE AN ISSUE WITH THE SYSTEM. QUALITY CONTROL AND SYSTEM CHECK DATA FROM THE TIME OF THE EVENT WAS NOT PROVIDED. THE CUSTOMER PROVIDED THE CSV FILE WHICH SHOWED THE SAMPLE RESULTS HAD AN ASSOCIATED CEX (CALIBRATION CURVE EXPIRED) FLAG FOR THE FT4 RESULTS FROM (B)(6) 2024. FT3 CALIBRATION PASSED ON (B)(6) 2024 WITH REAGENT LOT 472174 AND CALIBRATOR LOT 489929. FT4 CALIBRATION PASSED ON (B)(6) 2024 WITH REAGENT LOT 472176 AND CALIBRATOR LOT 439424. TSH CALIBRATION PASSED ON (B)(6) 2024 WITH REAGENT LOT 472145 AND CALIBRATOR LOT 439317.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821150 UNICEL DXI 800 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER 15099590265373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other