The caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.The following is a chronological order of events: (b)(6) /2015: inratio inr=1.6, strip# 334577.There was no increase in medication.The patient was taking coumadin 9mg.On (b)(6) 2015: inratio inr=1.4, strip# 349906.The patient's coumadin was increased from 9mg to 10mg.On (b)(6) 2015: the patient was hospitalized for a urinary tract infection (uti) and dehydration which was not related to the device.Patient was started on unspecified antibiotics.On (b)(6) 2015: laboratory inr=3.0 the variance between the inratio inrs and the laboratory inr can be explained by the increase in coumadin starting on (b)(6) 2015.On (b)(6) 2015: inratio=1.0, strip#349906.This is considered the date of the event since this was the start of the unexplained variance.On (b)(6) 2015: laboratory=2.4; inratio=2.5, strip# 349906.The testing was performed within 3 hours.There was no reported adverse patient sequela.There was no additional information provided.
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Investigation/conclusion: the customer reported discrepant low inratio inr results during testing.It is indicated that product is not returning for evaluation.Therefore, an investigation of the complaint to determine root cause cannot be completed.Since the product associated with the complaint was not returned, a review of in-house testing data was performed.Retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.A review of the manufacturing records for the lot did not uncover any non-conformances and the lot met release specification.A root cause could not be determined from the information provided by the customer.Based on the information available, there is no indication of a product deficiency and no corrective action is required at this time.
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