BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 21996717 · Received May 9, 2025

    Report

    Report Number
    3002637618-2025-00036
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 25, 2025
    Report Date
    June 3, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION WAS COMPLETED. ASSESSING THE PROVIDED INSTRUMENT DATA SHOWS ONE ¿SODIUM SENSOR INTERFERENT DETECTED¿ AND ONE ¿EXCESSIVE NA+ INTERFERENT DETECTED¿ MESSAGES ON THE DAY OF THE EVENT. THESE EVENTS ARE KNOWN INDICATIONS OF NA+ SENSOR EXPOSURE TO QUATERNARY AMMONIUM COMPOUNDS (QACS) SUCH AS BENZALKONIUM FOUND IN MANY SKIN DISINFECTANTS OR EXTERIOR CLEANERS. CUSTOMER BULLETINS INCLUDING AND THE RAPIDPOINT 500E OPERATOR¿S GUIDE RECOMMENDS NOT TO USE ANY SKIN DISINFECTING PRODUCTS AND/OR EXTERIOR DISINFECTANTS THAT CONTAIN QUATERNARY AMMONIUM COMPOUNDS (QAC) AS THEY ARE KNOWN INTERFERENTS TO THE RP500/500E NA+ SENSOR BY POTENTIALLY IMPACTING THE SENSOR AND ITS¿ PERFORMANCE AND SHOULD BE AVOIDED. THE CUSTOMER HAS THE ¿NA+ INTERFERENT WARNING¿ POP-UP ENABLED. THE ROOT CAUSE FOR DISCREPANT LOW NA+ RESULT GENERATED ON THE RP500E INSTRUMENT WAS DUE TO THE MOMENTARY INSTABILITY OF THE NA+ SENSOR CAUSED BY AN INTERFERENT SUCH AS A QAC EXPOSURE WHEN THE SAMPLE IN QUESTION WAS RUN. THE SOURCE OF QAC IS UNKNOWN. THE MEASUREMENT CARTRIDGE WAS REPLACED AND THE RP500E INSTRUMENT IS CURRENTLY OPERATIONAL. ON 30-MAY-2025, IT WAS VERIFIED THAT THE RESULTS PROVIDED WERE SWITCHED. SECTIONS B5, B6, AND H6 (MEDICAL DEVICE PROBLEM CODE) HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED INSTRUMENT FILES AND THE INVESTIGATION IS ONGOING. THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT LOW NA ON 1 PATIENT WHEN COMPARED TO REPEAT TESTING OF THE SAME SAMPLE ON A DIFFERENT RP500E INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED DISCREPANT HIGH NA ON 3 PATIENTS WHEN COMPARED TO REPEAT TESTING OF THE SAME SAMPLES ON A DIFFERENT RP500E INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968115 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC. 00630414286174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown