BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 20609890 · Received November 5, 2024

    Report

    Report Number
    3002637618-2024-00119
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    October 8, 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 AVAILABLE DATA LOGS FOR THE MEASUREMENT CARTRIDGE IN USE AT THE TIME OF THE EVENT WERE REVIEWED. THE CALIBRATION HISTORY, AQC PERFORMANCE AND RAW RESPONSES WERE ANALYZED. THE EVENTS LOG RECORDED AN EXCESSIVE NA+ INTERFERENT DETECTED EVENT WAS RECORDED ON 10/09/2024 AT 12:22 PM AND AGAIN ON 10/10/2024 AT 9:56. 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 INSTRUMENT MANUAL. 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. CUSTOMER BULLETINS AND THE INSTRUMENT MANUAL 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. ALL SAMPLES THAT PRODUCED DISCREPANT RESULTS WERE RUN AFTER INTERFERENT DETECTED EVENT ON 10/09/2024. IT IS NOTED THAT THE SAMPLES BEING COMPARED WERE FROM DIFFERENT DRAWS AND OFTEN COLLECTED AT DIFFERENT TIMES OF THE DAY. A REGRESSION ANALYSIS OF THE SODIUM AND POTASSIUM RESULTS FOUND AN OVERALL AGREEMENT BETWEEN THE RAPIDPOINT AND LAB ANALYZER. A TIMELINE FOR THE PATIENT SAMPLES FOUND THAT THE DISCREPANT RESULTS WERE INTERSPERSED BETWEEN SAMPLES THAT WERE IN CLOSE AGREEMENT WITH THE SECONDARY RESULTS. THE MEASUREMENT CARTRIDGE WAS REPLACED. THE INSTRUMENT IS PERFORMING AS INTENDED AND CURRENTLY OPERATIONAL AT THE CUSTOMER SITE.

    Additional Manufacturer Narrative · 0

    SIEMENS REQUESTED THE INSTRUMENT FILES FOR FURTHER INVESTIGATION. THE FILES HAVE BEEN PROVIDED AND INVESTIGATION IS UNDERWAY. THE CUSTOMER STATED THAT THEY BELIEVE THE ISSUE IS DUE TO BOTH IMPROPER SAMPLE HANDLING AND INSTRUMENT ERROR. THEY HAVE REPLACED THE MEASUREMENT CARTRIDGE AND ARE CURRENTLY OPERATIONAL. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RECEIVED A FALSELY LOW POTASSIUM (K+) RESULT ON ONE PATIENT COMPARED TO RETESTING 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
    1612249 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC. 00630414286174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown