Investigation conclusion update: the products associated with the complaint were returned for investigation.The customer's complaint of discrepant high results was not confirmed during in-house testing.Returned and retain strips tested on the returned meter met both accuracy and repeatability criteria.The returned meter met functional and thermistor testing requirements during investigation.Although relevant ncs were noted in batch record, it did not affect the final release specifications.There is no indication of a deficiency with the strips and additional corrective actions were not required.The impedance curve analysis associated with this case found two impedance curves which exhibited a weak slope change.Capa investigation (capa-(b)(4)) has determined that impedance curves with weak slope change can cause discrepant results.The inratio meter software may generate an incorrect or discrepant inr result when the patient sample exhibits a weak-slope change impedance curve.The capa investigation has also determined that certain patient conditions can contribute to weak slope change impedance curves.The customer did not report to have a medical condition that would interfere with the test.Although two technique issues were also identified in the complaint, root cause cannot be determined from the information provided.An impedance curve with weak-slope change has been identified in capa-(b)(4) to contribute to a potential discrepant result.Further investigation is being performed under capa-(b)(4) for this issue.
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