The caller alleged a variance between the inratio inr results and the laboratory inr result.Results are as follows: date: (b)(6) 2015, inratio inr: 4.0 and 3.8, laboratory inr: 2.4.Therapeutic range: 2.5 - 3.5.The time between the initial inratio test and the laboratory test was four (4) hours.The time between the laboratory test and the repeat inratio test was three (3 hours).The patient presented to the emergency room on (b)(6) 2015 for chest pains and diagnosed with unspecified chest pain.The patient was treated with tramadol and sent home.There was no reported adverse patient sequela.There was no additional information provided.
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Investigation/conclusion:
as of 10/19/2015, no product was returned for evaluation.Therefore, a review of in-house testing was performed.In-house strip testing on the reported strip lot had met criteria and the product performed as expected.The manufacturing records for the lot were reviewed and the lot met release specifications.It was reported that the customer has osteoarthritis.This condition may impact the performance of the assay.The 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.
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