The customer received questionable high results from coaguchek xs meter serial number (b)(4) compared to the laboratory results.One example was provided.At 940 am, the result from the meter was 5.5 inr.At 940 am, the result from a laboratory using dade innovin reagent was 2.97 inr.There was no allegation of an adverse event.The patient was not anemic, had no heparin, no antiphospholipid antibodies, no direct thrombin inhibitor, no change to coumadin dose, no new medication, no diet change, no illness, and no symptoms of bleeding or bruising.The therapeutic range was 2.0-3.0 inr.The suspect meter and strips were requested to be returned for investigation.The meter was received and was tested with quality control material and retention test strips.Qc 1: 2.4 inr; qc 2: 2.4 inr; qc 3: 2.4 inr.The obtained qc values were in the allowed range of the used combination master lot strip lot - qc lot.(1.9 - 2.9 inr).All measurements were without error messages.Retention test strips (lot 304975) were tested in comparison to masterlot #28632180.For this purpose, two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention material complies with specification.The results alleged by the customer were not observed in the meter¿s patient result memory.No information was provided in the complaint case that would point to a cause for the result discrepancy.Extensive measurements have shown higher deviations for coaguchek values > 4.5 inr compared to a laboratory method.Therefore, the customer allegation has been substantiated.A product problem has been found for coaguchek values > 4.5 inr, which was the case in this complaint.This can be traced back to the calibration of the complained test strips to the who standard rtf/16.For measurements > 4.5 inr.The customer is advised to contact the physician and perform a measurement with a laboratory method.Roche diagnostics has issued a recall for this issue.
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