The caller alleged a variance between the inratio inr result and the laboratory inr result.Results are as follows: date: 04/21/2015, inratio inr: na, laboratory inr: 1.1 (no medication change); date: 04/22/2015, inratio inr: 2.2, laboratory inr: n/a.Therapeutic range: 1.8 - 2.2.The customer reported that they are anemic.There was no reported adverse patient sequela.There was no additional information provided.
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Investigation/conclusion: 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-conformance and the lot met release specification.The patient was reported to be anemic, but hematocrit was not provided.Anemia with a hematocrit less than 30% was identified as a condition that may contribute to discrepant inr results.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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