Udi: (b)(4).The user reported an incident with discrepant patient results when compared to a reference analyzer while measuring pco2 with a statprofile prime ccs comp analyzer, serial number (b)(6).This event occurred on (b)(6) 2022.A formal investigation was unable to be performed due to the lack of returned sensor card(s) from china.A copy of the analyzer's database was returned to nova product development and reviewed.The database did not identify a root cause for the alleged result discrepancy.Device history record (dhr) reviews were performed for the analyzer and the consumables in use at the time of the event by a quality control engineer.The reviews included an assessment of the production, testing, and release of the analyzer and consumables.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the root cause for the alleged result discrepancy was unable to be identified, and if additional information becomes available, it will be reviewed to determine if additional investigation is warranted.Nova will continue to monitor for recurrence of similar events.
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