Investigation/conclusion: it is indicated that the meter is not returning for evaluation.Since the product associated with the complaint was not returned, a review of in-house testing was performed.A review of retain strip testing for lot# 334580 found the results met both accuracy and repeatability criteria.The product performed as expected and no product deficiencies were observed.Additionally, it was found that the release specification for lot# 334580 was within the calculated confidence interval of the percent flier rate for complaint investigation testing.No product deficiency was found for lot# 334580.The manufacturing records for lot# 334580 were reviewed.The lot met specifications and no non-conformances were documented.The customer reported the use of strip lot 334580 which expired in 03/2015.Using expired product may be a cause for the unexpected results experienced by the customer.The customer has lupus.Testing with an aps-insensitive laboratory method is recommended for these patients.The customer's blood sample may have interfered with the coagulation test and may have contributed to the unexpected results.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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