BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM

    MDR report key: 25078915 · Received May 5, 2026

    Report

    Report Number
    2517506-2026-00080
    Event Type
    Malfunction
    Date Received
    May 5, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 5, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414593579
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 A FALSELY DEPRESSED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON THE DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. QUALITY CONTROL (QC) AND CALIBRATION RESULTS WERE WITHIN ACCEPTABLE LIMITS PRIOR TO RUNNING THE PATIENT SAMPLE. THE CUSTOMER REPLACED SENSOR AND RAN DILUTION CHECK. SIEMENS REMOTELY ASSISTED THE CUSTOMER AND PERFORMED 3 INTEGRATED MULTISENSOR TECHNOLOGY (IMT) SOAKS, PRIMED ALL REAGENTS FOR 5 TIMES AND RAN QUALITY CONTROL (QC) AND REPEATED SAMPLE. SIEMENS REVIEWED THE AVAILABLE INSTRUMENT DATA FILES AND THE REVIEW OF THE INSTRUMENT DATA INDICATED THAT AIR AND LIQUID VALUES OF STD A AND STD B, CALIBRATION, PUMP RATE AND DILUTION CHECK WERE WITHIN THE ACCEPTABLE RANGE. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER¿S SITE. DURING THE VISIT, THE CSE IDENTIFIED CRIMPED XO TUBING AND SNIPPED THAT PRIMED AIR BUBBLES OUT OF XO TUBING, REPLACED X TUBING, RAN PASSING CALIBRATION, QC, AND DILUTION CHECK, WHICH RECOVERED ACCEPTABLY. SIEMENS EVALUATED THE EVENT AND DETERMINED THAT THE CRIMPED X0 TUBING AND ISSUE WITH X TUBING POTENTIALLY CONTRIBUTED TO THE FALSELY DEPRESSED POTASSIUM (K) RESULT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT A FALSELY DEPRESSED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM. THE ERRONEOUS RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO DID NOT QUESTION THE RESULT. THE SAMPLE WAS REPEATED ON THE ORIGINAL INSTRUMENT FOR TROUBLESHOOTING PURPOSES. THEN THE SAME SAMPLE WAS REPEATED ON NON-SIEMENS INSTRUMENT. THE REPEAT RESULT FROM NON-SIEMENS INSTRUMENT RECOVERED HIGHER THAN THE INITIAL RESULT AND WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO A FALSELY DEPRESSED K RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180037 DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200 INTEGRATED CHEMISTRY SYSTEM 00630414593579

    Patients

    Seq Age Sex Outcome Treatment
    1