Siemens investigation has been completed: the in-house performance for the card lot in question, 11-21110-30, did not identify any product deficiencies.When the correct reference ranges are applied, only po2 for patient 2 met psi criteria in the customer complaint.Therefore, the investigation focused on the in-house epoc performance for po2.Card lot 11-21110-30 was tested with arterialized blood and with aqueous control fluids eurotrol l1 and eurotrol l3 at the time of product release.Aqueous fluids and arterialized blood displayed no indication of discrepant results at the time of release.Aqueous fluids eurotrol l1 and l3 were tested on card lot 11-21110-30 throughout the product lifetime and displayed no indication of discrepant results.In addition, there were no other complaints received on card 11-21110-30.Therefore, there is no evidence that the system or reagent cards are not performing as intended.
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