Unique identifier (udi) (b)(4).Occupation is lay user/patient.The test strips were requested for investigation.The reporter's test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.3 - 3.5 inr): qc 1: 2.7 inr, qc 2: 2.7 inr, qc 3: 2.7 inr.The obtained qc values were in the allowed range of the used combination strip lot - qc lot.All measurements were without error messages.Routine retention testing is performed.Test strip retention samples passed the internal inspection.Retention testing data is reviewed and appropriate actions are taken as needed.Product labeling states: "the coaguchek system uses human recombinant thromboplastin.Therefore, the comparability to other human recombinant thromboplastins is best, whereas deviations can occur when compared to methods using other thromboplastins.However, those deviations between thromboplastins of different origin (e.G., rabbit based) are not specific to coaguchek products.Similar differences can be observed when a human recombinant thromboplastin based laboratory method is compared to other laboratory methods." the investigation did not identify a product problem.The cause of the event could not be determined.
|
We received a report of discrepant inr results for 1 patient tested with coaguchek xs meter serial number (b)(4) compared to an unknown laboratory method.At 4:36 pm, the result from the meter was 6.9 inr.At 6:30 pm, the result from the laboratory was 3.0 inr.The patient has a therapeutic range of 2.0-3.0 inr.
|