BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 20641599 · Received November 8, 2024

    Report

    Report Number
    3002637618-2024-00120
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 9, 2024
    Report Date
    November 27, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    UDI-DI
    00630414286174
    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

    THE PROVIDED INSTRUMENT DATA LOGS WERE REVIEWED. THE CALIBRATION HISTORY, AQC PERFORMANCE AND RAW RESPONSES FOR THE SENSORS IN THE MEASUREMENT CARTRIDGE WERE ANALYZED. THE EVENTS LOG RECORDED AN EXCESSIVE NA+ INTERFERENT DETECTED EVENT BEFORE AND AFTER THE TIME OF THE DISCREPANCY. THIS INDICATES THE DETECTION OF A QUATERNARY AMMONIUM COMPOUND TYPE OF EXPOSURE AND IS A KNOWN INTERFERENT OF THE RAPIDPOINT SODIUM AND POTASSIUM ASSAYS. A FEATURE IS AVAILABLE TO INFORM THE CUSTOMER OF SUCH AN EVENT AND CAN BE ENABLED PER THE INSTRUCTIONS IN THE RAPIDPOINT 500E OPERATOR¿S GUIDE. THE ¿EXCESSIVE NA+ INTERFERENT DETECTED¿ MESSAGE WILL POST TO BOTH THE STATUS AND RECALL EVENTS LOG AND REMAIN THERE UNTIL THE CARTRIDGE IS REPLACED. THE SOURCE CONTAINING QAC IS UNKNOWN BUT SHOULD BE IDENTIFIED AND ELIMINATED. 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. IT IS NOTED THAT THE SAMPLES BEING COMPARED WERE FROM DIFFERENT DRAWS AND COLLECTED AT DIFFERENT TIMES OF THE DAY. A REGRESSION ANALYSIS OF THE SODIUM RESULTS FOUND AN OVERALL AGREEMENT BETWEEN THE RAPIDPOINT AND LABORATORY ANALYZER. THE RAPIDPOINT SYSTEM INSTRUMENT IS PERFORMING AS INTENDED AND CURRENTLY OPERATIONAL AT THE CUSTOMER SITE.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED INSTRUMENT FILES FOR FURTHER INVESTIGATION. PRELIMINARY REVIEW SHOWED MULTIPLE SODIUM SENSOR INTERFERENT MESSAGES AROUND THE TIME OF THE EVENT. THE CUSTOMER IS UNSURE IF APPROPRIATE CLEANERS ARE BEING USED. THE CUSTOMER HAS BEEN ADVISED ON WHAT THE SODIUM INTERFERING SUBSTANCES ARE PER THE INSTRUMENT MANUAL. WHILE THE SAMPLE WAS RUN AFTER THE ERROR MESSAGES, THE SODIUM SENSOR RAW RESPONSE FOR THE SAMPLE IN QUESTION WAS TYPICAL AND THE SYSTEM APPEARS TO BE REPORTING RESULTS FOR THE SAMPLE AS IT WAS PRESENTED. IT IS NOTED THAT THE SAMPLES BEING COMPARED WERE FROM DIFFERENT DRAWS AND OFTEN COLLECTED AT DIFFERENT TIMES OF THE DAY. THE MEASUREMENT CARTRIDGE WAS REPLACED. THE INSTRUMENT IS PERFORMING AS INTENDED AND CURRENTLY OPERATIONAL AT THE CUSTOMER SITE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY HAD RECEIVED A FALSELY HIGH SODIUM (NA+) RESULT ON ONE PATIENT COMPARED TO RETESTING OF A NEW SAMPLES ON A LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044433 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC. 00630414286174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown