BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 16314909 · Received February 7, 2023

    Report

    Report Number
    3002637618-2023-00005
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 19, 2023
    Report Date
    March 29, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K192240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED THE INVESTIGATION. BASED ON REVIEW OF THE INSTRUMENT LOG FILE, THE ROOT CAUSE OF THE SUSPECTED LOW NA+ RESULTS WAS LIKELY DUE TO PRIOR EXPOSURES TO A SODIUM SENSOR INTERFERENT. THE SODIUM SENSOR EXPERIENCED EXPOSURE BY A NA+ SENSOR INTERFERING SUBSTANCE AS INDICATED BY A REVIEW OF THE NA+ SENSOR REAGENT RESPONSE CURVE, RECALL EVENTS AND SUMMARY REPORT OF THE SYSTEM. THE PATTERN SEEN IS CHARACTERISTIC OF AN EXPOSURE TO QUATERNARY AMMONIUM COMPOUND MATERIALS (QAC) WHICH ARE KNOWN TO INTERFERE WITH THE NA+ SENSOR.

    Additional Manufacturer Narrative · 0

    PRELIMINARY INVESTIGATION INTO THE RP500E EVENT LOGS SHOWS SEVERAL EXPOSURES TO SODIUM INTERFERENTS. FURTHER INVESTIGATION UNDERWAY.

    Description of Event or Problem · 0

    THE CUSTOMER HAS REPORTED THEIR RP500E IS REPORTING DISCREPANT SODIUM RESULTS WHEN COMPARED TO TESTING NEW SAMPLES ON A NON-SIEMENS LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967457 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown