Siemens has requested instrument files for further investigation however the customer did not provide them.The in-house performance of sodium for the card lot in question was reviewed.Aqueous fluids and arterialized blood performed as expected and met product specifications at the time of release.Additional testing was performed with blood representative of the customer testing range.All epoc test results were centered within the allowable total error and comparable to test results provided by other blood gas analyzers.Differences in instrument methodologies cannot be ruled out as a root cause of the alleged sodium discrepancy(ies) at the customer site.Therefore, there is no evidence that the system or reagent cards are not performing as intended the cause of this event is unknown.
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