BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 18152433 · Received November 16, 2023

    Report

    Report Number
    2517506-2023-00241
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Date of Event
    October 12, 2023
    Report Date
    December 4, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.Y
    Product Code
    JJE
    UDI-DI
    00630414593579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 2517506-2023-000241 WAS SUBMITTED TO THE FDA ON 16-NOV-2023. ADDITIONAL INFORMATION (29-NOV-2023): SIEMENS EVALUATED THE AVAILABLE DATA AND FOUND THAT THE CUSTOMER IS USING THE ARK METHOTREXATE REAGENT ON THE DIMENSION EXL. THE ARK METHOTREXATE REAGENT IS NOT VALIDATED AND IS NOT SUPPORTED FOR USE ON THE DIMENSION EXL. THE ARK METHOTREXATE REAGENT IS CONFIGURED AS A USER DEFINED ASSAY ON THE DIMENSION EXL AND THE TECHNICAL PERFORMANCE OF THE ASSAY CANNOT BE EVALUATED. AN EVALUATION OF AN INSTRUMENT LOG FILE DID NOT FIND AN ENTRY FOR SAMPLE ID (B)(6). SIEMENS CANNOT CONFIRM AN ANALYZER ISSUE. THE CAUSE OF THE ARK METHOTREXATE TEST RESULT DISCORDANCE IS UNKNOWN. THE ANALYZER IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THIS ANALYZER IS NEEDED. MDR 2517506-2023-000242 WAS SUBMITTED FOR THE SAME EVENT. SECTION H6 ADVERSE EVENT PROBLEM CODES WERE UPDATED.

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS TO REPORT THAT ONE SAMPLE WAS TESTED FOR METHOTREXATE (TX) ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE CUSTOMER INFORMED SIEMENS THAT THE PATIENT WAS STARTED ON FOLINIC ACID TO BEGIN THE MXT RESCUE (DECREASE THE CONCENTRATION OF MTX) AT THE END OF TREATMENT WITH MTX. THE SAMPLE WAS TAKEN AND TESTED FOR MTX TO CONTROL IF THE CONCENTRATION OF MTX WAS LOW ENOUGH TO STOP THE RESCUE. THE RESCUE WAS STOPPED UNTIL THE REPEAT TEST WAS OBTAINED AND THEN THE RESCUE WAS RESUMED. SIEMENS IS INVESTIGATING.

    Description of Event or Problem · 0

    ON (B)(6) 2023 ONE PATIENT SAMPLE WAS TESTED FOR METHOTREXATE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE SAMPLE WAS REPEATED WITH DILUTION AND THE RESULT DEEMED INCONSISTENT. A PATIENT WHO RECEIVED METHOTREXATE WAS GIVEN A RESCUE TREATMENT WITH FOLINIC ACID. THE CUSTOMER REPORTED THAT THE RESCUE TREATMENT WITH FOLINIC ACID WAS NOT COMPLETELY CORRECT DUE TO THE RESULTS OF THE SAMPLE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO STOPPING THE FOLINIC ACID RESCUE PREMATURELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912705 DIMENSION EXL 200 ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE SIEMENS HEALTHCARE DIAGNOSTICS INC.Y DIMENSION EXL 200 00630414593579

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown