Occupation is lay user/patient.The test strips were requested for investigation.The customer's test strips were provided for investigation where they were tested using a retention meter and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 3.0 inr.Qc 2: 3.2 inr.Qc 3: 3.0 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Relevant retention test strips (lot 417474) were tested in comparison with the master lot coaguchek xs pt.For this purpose two human blood samples from marcumar donors and two internal reference meters were used.Retention samples were acceptable.No error messages occurred.The investigation did not identify a product problem.The cause of the event could not be determined.Per product labeling, "coaguchek uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas higher deviations can occur with other thromboplastins.However, those higher differences between thromboplastins of different (rabbit, bovine based) origin are not a coaguchek specific issue.Similar differences can be observed when a human recombinant thromboplastin-based laboratory method is compared against several other (rabbit, bovine-based) laboratory methods.".
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