It was reported on (b)(6) 2016: warfarin - 2.5mg x5/day and 5mg x2/day; no recent changes per hcp.Treatment was given based on the lab results.No additional information available regarding treatment provided based on lab results.Therefore, adverse event added to mdr.Required intervention to prevent permanent impairment/damage added to mdr.Correction: it was reported on (b)(6) 2016 the inratio value on 07/19/2016 was 10.3 not 1.3.Lab inr on (b)(6) 2016 remained at 2.3.Correction: serious injury.Investigation/conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire in-house testing history of the lot was performed.In-house testing on the reported strip lot met release criteria.The product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.Although technique and user issues were identified in the complaint, 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.No corrective action is required at this time.
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