Based on the review and analysis of the provided data for the instrument log with the measurement cartridge installed, aqc expected recovery, raw signal responses, reagent response curves, and calibration history; the root cause for the low na+ result recoveries for the escalated patient samples in question were due to an unstable na+ sensor.The na+ sensor was exposed to quaternary ammonium compounds (qac).The customer confirmed the use of clinell wipes.Per the customer bulletin 2020-12 (cust-00271-edg): ¿exterior disinfecting cleaners for the rapidpoint® 405/500/500e systems¿ and the rapidpoint 500 operator¿s guide, any cleaning agent that contains benzalkonium or other quaternary ammonium compounds as an ingredient should not be used as an exterior disinfectant for the rapidpoint 405/500/500e systems and sampling devices used for blood gas analysis.These substances are known interferents to the na+ sensor and can destabilize the sensor, causing calibration issues, and significantly impacting results; therefore, should be avoided.The source containing qac should be identified and eliminated.The rp500 instrument is currently operational at the customer site.
|