The customer reported discrepant creatinine results on a statsensor meter sn (b)(6) while using strips with lot number 4921209129.The results were questioned and the samples were run on a lab chemistry analyzer which confirmed the discrepant values.The patient was not treated based off of the results from the meter and there were no adverse interactions.There was no patient harm or intervention reported.Dhr reviews for the statsensor meter and test strips were performed by a quality control engineer.The reviews included an assessment of the production, testing, and release of the meter, test strip batch, and control solutions.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.The retained test strips met all performance acceptance criteria for whole blood and linearity testing.The customer's complaint could not be reproduced and no root cause was able to be identified.Nova will continue to monitor for recurrence as part of our post market surveillance program.
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