BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM

    MDR report key: 21629432 · Received March 18, 2025

    Report

    Report Number
    2517506-2025-00047
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 20, 2025
    Report Date
    March 18, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414593500
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A UNITED STATES (US) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED THAT FALSELY ELEVATED POTASSIUM (K) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE AUTO-VERIFIED IN THE LABORATORY INFORMATION SYSTEMS (LIS) WHEN FLAGGED WITH A HIGH HEMOLYSIS, ICTERUS, AND LIPEMIA (HIL) VALUE. THE CUSTOMER STATED THAT THE LIS RELEASED THE ERRONEOUS RESULTS FLAGGED WITH AN "H" VALUE INSTEAD OF BEING HELD. A SIEMENS TECHNICAL APPLICATION SPECIALIST (TAS) WAS DISPATCHED TO THE CUSTOMER¿S SITE. DURING THE VISIT, THE TAS INSPECTED THE INSTRUMENT, VERIFIED THE HIL CONFIGURATION SETTINGS AND CHANGED IT FROM "ON" TO "AUTO-ON." FOLLOWING THIS ADJUSTMENT, THE ATELLICA DATA MANAGER (ADM) SUCCESSFULLY HELD RESULTS FLAGGED FOR HIL. AFTER THE NEW SETTING CHANGE THE INSTRUMENT HELD HIL FLAG WITHOUT REPORTING. SIEMENS EVALUATED THE EVENT AND CONCLUDED THAT HIL AUTO-ON SETTINGS NOT ENABLED IN THE SYSTEM, POTENTIALLY CONTRIBUTED TO THE FALSELY ELEVATED K RESULTS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT FALSELY ELEVATED POTASSIUM (K) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON A DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE AUTO-VERIFIED IN THE LABORATORY INFORMATION SYSTEMS (LIS) WHEN FLAGGED WITH A HIGH HEMOLYSIS, ICTERUS, AND LIPEMIA (HIL) VALUE. THE CUSTOMER STATED THAT THE LIS RELEASED THE ERRONEOUS RESULTS FLAGGED WITH AN "H" VALUE INSTEAD OF BEING HELD. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND IT IS UNKNOWN IF THE RESULTS WERE QUESTIONED AND IF THE SAMPLES WERE REPEATED. THE CUSTOMER DID NOT PROVIDE THE PATIENT RESULTS DATA TO SIEMENS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED K RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1586421 DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM INTEGRATED CHEMISTRY SYSTEM 00630414593500

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown