BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500E BLOOD GAS SYSTEM

    MDR report key: 13860089 · Received March 23, 2022

    Report

    Report Number
    3002637618-2022-00020
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 22, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    PMA / PMN Number
    K192240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER PROVIDED INSTRUMENT LOG FILES FOR FURTHER INVESTIGATION. BASED ON THE INSTRUMENT LOG REVIEW, THE ROOT CAUSE FOR THE SUSPECTED DISCREPANT LOW SODIUM RESULT WHEN COMPARED TO REPEATED NA+ RESULTS GENERATED ON THE LAB INSTRUMENT WAS DUE TO AN UNSTABLE NA+ SENSOR WITHIN THE MEASUREMENT CARTRIDGE. THE NA+ SENSOR WAS EXPOSED TO A QUATERNARY AMMONIUM COMPOUND (QAC) SUCH AS BENZALKONIUM OR CHLORHEXIDINE, NOTED AS A "SODIUM SENSOR INTERFERENT DETECTED'' ERROR. THE CUSTOMER STATED THAT THEY USE CLEANING WIPES THAT CONTAIN A QAC. THE CUSTOMER HAS REPLACED THE MEASUREMENT CARTRIDGE AND HAS BEEN INSTRUCTED TO CEASE USING DISINFECTANTS CONTAINING QACS. THE CUSTOMER IS OPERATIONAL.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A DISCREPANT LOW SODIUM RESULT FROM THEIR RP500E INSTRUMENT COMPARED TO REPEAT TESTING OF THE SAME SAMPLE ON A NON-SIEMENS LAB INSTRUMENT. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864686 RAPIDPOINT 500E BLOOD GAS SYSTEM RP 500E CHL SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown