A variance was reported between inratio inr results and lab inr result.The results were as follows: (b)(6) 2016: inratio=6.3, lab=1.2, inratio=1.2; unknown therapeutic range.On (b)(6), nurse took inr on inratio monitor and received a 6.3.Immediately after, took venous draw from the patient's arm and went to the lab and received a 1.2 from lab.Came home to retest on monitor and received a 1.2 on inratio monitor.It was also reported that the patient is on unspecified antibiotics; no dosage provdied.
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The product was not returned for evaluation.Therefore, a review of the entire testing history for the reported lot was performed.In-house testing on strip lot 370105ar meets release criteria.The product performed as expected.A review of the manufacturing records for the lot did not uncover any relevant non-conformances; the lot met release specifications.A root cause could not be determined from the available information.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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