BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 23052547 · Received September 15, 2025

    Report

    Report Number
    3002637618-2025-00069
    Event Type
    Malfunction
    Date Received
    September 15, 2025
    Date of Event
    September 6, 2025
    Report Date
    October 13, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    UDI-DI
    00630414286174
    PMA / PMN Number
    K192240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH REVIEW OF THE SYSTEM DATA LOGS FROM THE CUSTOMER'S RP500E INSTRUMENT WAS CONDUCTED REGARDING THE ESCALATED DISCORDANT SODIUM RESULTS FOR A SINGLE PATIENT. THE SYSTEM REGISTERED A ¿SODIUM SENSOR INTERFERENT DETECTED¿ EVENT IMMEDIATELY FOLLOWING THE FIRST ESCALATED SAMPLE. THIS WAS CORROBORATED BY THE DRIFT IN SODIUM SENSOR RAW RESPONSE SIGNALS FOR BOTH ESCALATED SAMPLES. ADDITIONALLY, 9 OTHER INSTANCES OF INTERFERENCE DETECTION WERE RECORDED IN THE USE LIFE OF THIS CARTRIDGE. THE CUSTOMER USES SEVERAL SKIN AND INSTRUMENT DISINFECTANTS WHICH CONTAIN QUATERNARY AMMONIUM COMPOUNDS (QACS). QACS ARE KNOWN INTERFERENTS OF THE RAPIDPOINT SODIUM SENSOR. THE ISSUE IS RESOLVED AFTER REPLACING THE MEASUREMENT CARTRIDGE AND THE INSTRUMENT IS OPERATING AS INTENDED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS PROVIDED INSTRUMENT LOG FILES FOR FURTHER INVESTIGATION. A PRELIMINARY REVIEW NOTED THERE WERE SODIUM SENSOR INTERFERENT ERRORS ON THE DAY OF THE EVENT. INVESTIGATION IS UNDERWAY. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY RECEIVED DISCREPANT SODIUM RESULTS ON THEIR RP500E INSTRUMENT COMPARED TO REPEAT TESTING OF A DIFFERENT SAMPLE ON THEIR LABORATORY ANALYZER. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1777840 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC. 00630414286174

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Unknown