BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 19159496 · Received April 22, 2024

    Report

    Report Number
    3002637618-2024-00042
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    April 13, 2024
    Report Date
    May 13, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K122539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FIELD SERVICE ENGINEER PERFORMED A CHECK ON THE ANALYZER AND FOUND THE SYSTEM TO BE OPERATIONAL. THE CUSTOMER PROVIDED INSTRUMENT LOG FILES TO BE INVESTIGATED. A PRELIMINARY REVIEW SHOWED A SODIUM INTERFERENT WAS DETECTED ON THE DAY OF THE DISCREPANT RESULT. INVESTIGATION IS CURRENTLY ONGOING TO DETERMINE IF THIS WAS THE CAUSE OF THE EVENT. CAUSE OF EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    SIEMENS COMPLETED THE INVESTIGATION. AN EXAMINATION OF THE SODIUM SENSOR CALIBRATION TRACE LOG, SYSTEM EVENTS LOG, AND AUTOMATIC QUALITY CONTROL RESULTS FROM THE CUSTOMER INSTRUMENT SHOWS THAT THE SODIUM SENSOR WAS EXPERIENCING A PERIOD OF INSTABILITY DURING TIME OF ANALYSIS OF THE ESCALATED SAMPLES. THE EVENTS LOG SHOWS ¿SODIUM SENSOR INTERFERENT DETECTED¿ EVENTS OCCURRED FREQUENTLY THROUGHOUT MEASUREMENT CARTRIDGE USE LIFE THIS IS INDICATIVE OF SENSOR INSTABILITY RESULTING FROM EXPOSURE TO A SODIUM SENSOR INTERFERENT SUCH AS QUATERNARY AMMONIUM COMPOUNDS (QAC). CUSTOMER BULLETINS AND THE RAPIDPOINT 500 OPERATOR¿S GUIDE RECOMMENDS NOT TO USE ANY SKIN DISINFECTING PRODUCTS AND/OR EXTERIOR DISINFECTANTS THAT CONTAIN 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 SOURCE CONTAINING QAC SHOULD BE IDENTIFIED AND ELIMINATED. THE ROOT CAUSE WAS DUE TO USER ERROR.

    Description of Event or Problem · 0

    CUSTOMER ALLEGES DISCREPANT SODIUM (NA+) RESULTS WHEN COMPARED TO RETESTING OF A DIFFERENT SAMPLE ON THEIR LABORATORY ANALYZER. THERE WAS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1842709 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male