Caller alleged discrepant low inratio inr result in comparison to the laboratory inr result.Results are as follows: date, inratio inr, laboratory inr: (b)(6) 2015, 2.6, 6.5.The time between testing was 30-45 minutes.Reportedly, the strips are past their expiration date and "milking" finger after finger stick therapeutic range 1.9 - 3.1 for the patient.There was no reported adverse event.There was no additional information provided.
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Investigation/conclusion: it is indicated that product is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed while the strips were still within expiration.Retain strip testing results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed while the product was within expiration.The manufacturing records for the lot were reviewed.The lot met specifications and no non-conformances were documented.An improper technique was identified in the complaint.This could not be ruled out as a cause of the unexpected results.Customer is using a strip lot that expired on april 2014.Using expired product may be a root cause for the unexpected results experienced 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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