The customer called and alleged variances between the inratio inr results.Results are as follows: (b)(6).During the above referenced dates and inratio inr results, the customer was taking warfarin 6mg 4x/week and 9mg 3x/week and no changes were made to the dose.(b)(6).After a dosage change, the effect should stabilize within 3-5 days sometimes longer, depending upon the patient, the stability of the dosing change, diet, etc.Therapeutic range: 2.5 - 3.5.There was no reported adverse patient sequela.There was no additional information provided.
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Investigation/conclusion: the customer did not provide any laboratory reference values for comparison.The accuracy of the customer's inratio results cannot be determined without this information.It is indicated that the product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.The retain strip testing results met both accuracy and strip 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 relevant non-conformances and the lot met release specification.The root cause is unable to be determined from the information provided.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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