The customer complained of erroneous inr results on coaguchek meter with serial number (b)(4).The customer initially tested on the meter and obtained a result of 6.2 inr at 9:00 a.M.The customer reported this result to her healthcare provider.The customer discovered that she was using expired test strips at the time of this result.The customer alleged that the meter did not produce an error message at the time of the erroneous result while using expired strips.The customer stated the time and date was set correctly and she was using the correct code key at the time of the 6.2 inr result.The customer switched to a new, non-expired vial of test strips and re-tested on the meter using a different finger at 10:00 a.M.And obtained a result of 1.8 inr.This result was also reported to the customer¿s healthcare provider.The customer re-tested again using another different finger at 10:30 a.M.And obtained a result of 1.8 inr.The customer and her doctor believe the result of 1.8 inr was correct.The customer¿s therapeutic range is 2.0 3.5 inr.No adverse event occurred.The customer feels ok.The new, non-expired test strip lot number was 15288123 with an expiration date of 28-feb-2018.The meter has never been cleaned.The customer has no hct issues and does not have antiphospholipid antibodies.The customer¿s coumadin dose has not been changed nor has her diet changed.She has bruises frequently and sometimes bleeding, however, no medical treatment has been necessary.The meter and test strips were requested for investigation; however, neither strip vial is available for return.Relevant retention test strips (lot 152881-23) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 124158-80).For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention material was acceptable.
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