BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPIDPOINT 500 BLOOD GAS ANALYZER

    MDR report key: 21232444 · Received January 24, 2025

    Report

    Report Number
    3002637618-2025-00009
    Event Type
    Malfunction
    Date Received
    January 24, 2025
    Date of Event
    January 19, 2025
    Report Date
    February 3, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHL
    UDI-DI
    00630414590844
    PMA / PMN Number
    K122539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ASSESSMENT OF THE INSTRUMENT DATA PROVIDED BY THE CUSTOMER SHOWED ¿SODIUM SENSOR INTERFERENT DETECTED¿ MESSAGES ON THE DATE OF THE EVENT, 10 MINUTES BEFORE THE REPORTED SAMPLE MEASUREMENTS. THIS IS AN INDICATION OF NA+ SENSOR EXPOSURE TO QUATERNARY AMMONIUM COMPOUNDS (QACS) SUCH AS BENZALKONIUM FOUND IN MANY SKIN DISINFECTANTS OR EXTERIOR CLEANERS. PER THE CUSTOMER BULLETINS AND THE RAPIDPOINT 500 OPERATOR¿S GUIDE IT IS RECOMMENDED 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. THE SOURCE CONTAINING QAC WAS NOT DISCLOSED TO SIEMENS HOWEVER IT HAS BEEN RECOMMENDED THAT THEY IDENTIFY AND CEASE USE OF THE SOURCE. THE ROOT CAUSE FOR THE DISCREPANT LOW NA+ RESULT WAS DUE TO USER ERROR FROM THE MOMENTARY INSTABILITY OF THE NA+ SENSOR FROM AN INTERFERENT WHEN THE SAMPLES IN QUESTION WERE RUN. THE MEASUREMENT CARTRIDGE WAS CHANGED AND THE INSTRUMENT IS PERFORMING AS INTENDED AND IS CURRENTLY OPERATIONAL.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPLACED THE MEASUREMENT CARTRIDGE AND THE SYSTEM IS OPERATIONAL. THE CUSTOMER PROVIDED INSTRUMENT FILES FOR FURTHER INVESTIGATION. INVESTIGATION IS UNDERWAY. THE CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A DISCREPANT LOW NA+ RESULT ON A PATIENT SAMPLE WHEN COMPARED TO A REPEAT ON THEIR LABORATORY ANALYZER. THE CUSTOMER DID NOT STATE IF THE SAME SAMPLE WAS USED FOR BOTH TESTS. THERE IS NO REPORT OF INJURY DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1146142 RAPIDPOINT 500 BLOOD GAS ANALYZER RP 500 CHL SIEMENS HEALTHCARE DIAGNOSTICS INC. 00630414590844

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown