BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 21125106 · Received January 10, 2025

    Report

    Report Number
    3002637618-2025-00004
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 9, 2024
    Report Date
    February 5, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC., POC HQ
    Product Code
    CHL
    PMA / PMN Number
    K192240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER HAS PROVIDED INSTRUMENT FILES FOR FURTHER INVESTIGATION. INVESTIGATION IS UNDERWAY. THE CUSTOMER HAS RUN CALIBRATIONS AND QC AND THE INSTRUMENT IS OPERATIONAL. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE PROVIDED INSTRUMENT FILES FOR POTASSIUM (K+) INDICATES THAT THE INSTRUMENT WAS PERFORMING AS INTENDED FOR THE DURATION OF THE MEASUREMENT CARTRIDGE USE-LIFE. NO K+ SENSOR ERROR FLAGS WERE OBSERVED, CALIBRATION AND RAW SAMPLE RESPONSE PROFILES APPEARED TYPICAL, AND ALL AQC SAMPLES RECOVERED WITHIN THE PUBLISHED LIMITS. THE K+ SENSOR WAS PERFORMING AS INTENDED AT TIME OF ANALYSIS OF THE ESCALATED SAMPLE. DIFFERENCE IN MATRICES (WHOLE BLOOD VS SERUM) MAY HAVE IMPACTED THE DISCREPANT RESULTS. A DEFINITIVE ROOT CAUSE OF THIS ISSUE CANNOT BE DETERMINED. THE INSTRUMENT IS CURRENTLY INSTALLED AND PERFORMING AS INTENDED AT THE CUSTOMER SITE. THE INSTRUMENT REMAINED OPERATIONAL WITHOUT CHANGING THE MEASUREMENT CARTRIDGE. THE CAUSE OF THIS EVENT IS UNKNOWN. NO PRODUCT PROBLEM IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEY RECEIVED A DISCREPANT HIGH POTASSIUM (K+) RESULT ON ONE PATIENT COMPARED TO RETESTING OF A NEW SAMPLE ON THEIR LABORATORY INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657724 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS, INC., POC HQ

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male