This event occurred in (b)(6).Occupation is lay user/patient.The test strips were requested for investigation.Two vials of the reporter's test strips were provided for investigation where they were tested using retention controls.Testing results (qc range: 2.6 - 3.2 inr): vial #1 qc 1: 3.0 inr, qc 2: 3.0 inr, qc 3: 3.0 inr.Vial #2 qc 1: 3.0 inr, qc 2: 2.9 inr, qc 3: 2.9 inr.Relevant retention test strips (lot 397397) 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.All inr values were within the specified maximum difference between measurements.No error messages occurred.The returned material and the retention material meet specifications.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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