The customer complained of discrepant inr results with coaguchek xs serial number (b)(4).At 12:10 pm, the meter result was 2.0 inr.At 12:16 pm, the meter result was 2.7 inr.The same finger was used as was used for the result of 2.0 inr.At 12:19 pm, the meter result was 1.9 inr.At 12:41 pm, the meter result was 2.8 inr.Customer's therapeutic range is 2.5-3.5 inr.The customer tests on a weekly basis.
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Initial reporter occupation is patient/consumer.Customer's daughter reported the comparison.The test strips were requested for investigation.The product has not been returned.If the product is returned in the future, a follow up report will be submitted.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The investigation did not identify a product problem.The cause of the event could not be determined.
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