The patient stated that he received erroneous results when testing with coaguchek xs meter serial number (b)(4) on (b)(6) 2018.On (b)(6) 2018 at 8:47 a.M., a sample from the patient was tested on the meter, resulting as 3.4 inr.On (b)(6) 2018 at 8:55 a.M., a sample from the patient was tested on the meter, resulting as 2.4 inr.On (b)(6) 2018 at 8:57 a.M., a sample from the patient was tested on the meter, resulting as 2.5 inr.After the meter measurements performed on (b)(6) 2018, the patient had dental surgery.The dental surgery was not related to meter testing.On (b)(6) 2018 at 5:29 p.M., a sample from the patient was tested on the meter, resulting as 3.4 inr.On (b)(6) 2018 at 5:31 p.M., a sample from the patient was tested on the meter, resulting as 3.0 inr.On (b)(6) 2018 at 7:00 p.M., a sample from the patient was tested on the meter, resulting as 2.5 inr.On each date, all sample measurements were performed with samples collected from the same puncture site on the same finger.No adverse events were alleged to have occurred with the patient.The patient did not receive any treatment based on the meter results.The patient's therapeutic range is 2.0 - 3.0 inr.The patient's testing frequency is once per week.The patient is not anemic and does not have antiphospholipid antibodies.The patient does not take heparin or direct thrombin inhibitors.The patient is not eating hard foods.The patient's product was requested for investigation and replacement product was sent to the patient.The patient used all remaining strips in the bottle he was using.Relevant retention test strips (lot 247896-43) were tested in comparison with the current master lot test strips.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were within specifications.The patient's meter was returned for investigation.The returned meter and a retention meter were tested with the master lot test strips and samples from donors.Donor 1 inr: 2.7 inr, donor 2 inr: 4.2 inr.Donor 1 hct: 41%, donor 2 hct: 40%.Testing results: donor 1: retention meter with masterlot strips: 2.8 inr, customer meter with masterlot strips: 2.8 inr.Donor 2: retention meter with masterlot strips: 4.2 inr, customer meter with masterlot strips: 4.2 inr.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.
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