BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 24445128 · Received February 25, 2026

    Report

    Report Number
    3002637618-2026-00011
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 15, 2026
    Report Date
    March 16, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    UDI-DI
    00630414286174
    PMA / PMN Number
    K192240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED INSTRUMENT FILES FOR INVESTIGATION AND THE INVESTIGATION IS ONGOING. THE CAUSE OF THIS EVENT IS UNKNOWN. THE CUSTOMER STATES THEY ARE CURRENTLY OPERATIONAL ON THE INSTRUMENT.

    Additional Manufacturer Narrative · 0

    A REVIEW OF AVAILABLE INSTRUMENT LOGS AND DATA INDICATES THAT THE SODIUM SENSOR WAS EXPERIENCING A PERIOD OF INSTABILITY AT TIME OF ANALYSIS OF THE ESCALATED SAMPLES. NUMEROUS SODIUM RELATED ERRORS AND INTERFERENT MESSAGES WERE OBSERVED ON THE DATE OF EVENT AND THE DAY PRIOR. ADDITIONALLY, AQC WAS RECOVERING OUT OF RANGE. THE DATA SHOWS CHARACTERISTICS OF EXPOSURE TO QUATERNARY AMMONIUM COMPOUNDS (QAC). THE CUSTOMER STATES EXTERIOR DISINFECTION IS OCCASIONALLY PERFORMED USING DIDECYLDIMETHYLAMMONIUM CHLORIDE, A KNOWN QAC. QACS ARE KNOWN INTERFERENTS OF THE RAPIDPOINT SODIUM SENSOR. THE INSTRUMENT IS CURRENTLY OPERATIONAL AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT LOW SODIUM ON THREE PATIENTS WHEN COMPARED TO REPEAT TESTING ON OTHER RP500E INSTRUMENTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273374 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC. 00630414286174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown