Conclusion: it is indicated that the product is not returning for evaluation.Therefore, a review of the entire testing history for the reported lot was performed.In-house testing on strip lot 384085a 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.Technique and user issues were identified in the complaint which may have contributed to the unexpected results observed 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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Caller reported discrepant inratio results.Results as follows: date: 4/20/2016, inratio:1.1, re-test: 2.0.Time between tests: 5 minutes.The following historical inratio value was provided: date: 4/13/2016, inratio: 2.1.Therapeutic range: 2.0-3.0.The patient self tester stated he was milking the finger during the re-test and not applying the blood within 15 seconds of sticking the finger on the first test.No report of death or serious injury.
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