Siemens healthcare diagnostics inc.Has confirmed an issue with rapidpoint 500 systems measurement cartridges (with lactate).This issue has the potential to affect the sodium (na+) sensor, as well as cause a question result ¿-----?¿ error flag for multiple electrolytes on patient samples and quality control.When the na+ sensor is affected, na+ slope calibration errors (d3) will be seen in the recall events log during cartridge initialization, resulting in low na+ values.The maximum sodium bias on internal testing and reported by customers comparing results to other direct method analyzers was <10 mm.To date, the impact to na+ results has been observed in less than 1% of the rapidpoint 500 systems measurement cartridges (with lactate).The question result ¿-----?¿ error flag has been observed on electrolytes.This may occur at any time over the life of the cartridge.Based on the investigation, these issues are due to an electronic noise that is observed on rapidpoint 500 systems measurement cartridges (with lactate).Measurement cartridges without lactate are not affected.Siemens has released a notification "potential for low na+ values and question result error flags" to inform customers of the issue and provide workaround options.Crr# 3002637618-11-01-2023-0004.
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