BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 19561493 · Received June 18, 2024

    Report

    Report Number
    3002637618-2024-00070
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    March 30, 2024
    Report Date
    August 6, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K192240
    Removal / Correction Number
    3002637618-09-26-2023-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER A THOROUGH REVIEW OF THE SYSTEM DATA LOGS, THE ROOT CAUSE FOR THE HIGH DISCREPANT SODIUM RESULTS APPEARS TO BE SAMPLE SPECIFIC AND NOT CAUSED BY A SENSOR OR SYSTEM MALFUNCTION. AN IMMEDIATE INTERFERENCE RESPONSE TO EACH OF THE FIVE ESCALATED BLOOD SAMPLES WAS NOTED IN THE SODIUM SENSOR TRACELOGS AS WELL AS IN RECORDED EVENTS LOG. THE DRUG PERHEXILINE IS A KNOWN INTERFERENT OF THE RAPIDPOINT SODIUM SENSOR (REFER TO URGENT FIELD SAFETY NOTIFICATION POC 23-018.A.OUS). IT NOTIFIES THE CUSTOMER OF A RISK OF REPORTING HIGH BIAS IN SODIUM RESULTS FOR PATIENTS ON THIS DRUG. THE INTERFERENCE WITH PERHEXILINE IS DEPENDENT ON THE EXPOSURE LEVEL FROM THE PATIENT BLOOD SAMPLE. EACH OF THE FIVE ESCALATED SAMPLES HAD TRIGGERED THE INTERFERENCE DETECTION ALGORITHM THAT INTRODUCES AN ADDITIONAL CALIBRATION (RETROCAL) FOR THE NEXT SAMPLE BEING RUN ON THE M-CART. IN THE ABSENCE OF ANOTHER SAMPLE, THE EXPOSURE TO INTERFERENCE IS CAPTURED IN THE NEXT CALIBRATION CYCLE. THIS IS A SAFEGUARD AGAINST REPORTING PATIENT RESULTS DUE TO THE TEMPORARY INSTABILITY IN SENSOR PERFORMANCE CAUSED BY THE INTERFERENT. THE OBSERVED DISCREPANT NA+ RESULTS ARE CONSISTENT WITH PERHEXILINE INTERFERENCE. 3002637618-09-26-2023-002-C.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS PROVIDED INSTRUMENT FILES. SEVERAL 'SODIUM INTERFERENT DETECTED' ERROR MESSAGES WERE NOTED ON THE DAY OF THE EVENT. THE CUSTOMER STATED THAT THE PATIENT WAS TAKING PERHEXILINE WHICH IS A KNOWN SODIUM SENSOR INTERFERENT. FURTHER INVESTIGATION IS UNDERWAY TO DETERMINE IF THE INTERFERENCE IS THE CAUSE OF THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT HIGH SODIUM (NA+) RESULT COMPARED TO RETESTING OF THE SAME 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
    936545 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown