Occupation is patient/consumer.The patient's (1) test strip was returned for investigation and was tested using a retention meter and retention controls.Testing results (qc range = 2.4 - 3.6 inr): qc 1: 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.On a regular basis, coaguchek strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.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." the investigation did not identify a product problem.The cause of the event could not be determined.
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There was an allegation of questionable results from coaguchek xs meter serial number (b)(4) compared to a laboratory result using a stago compact max analyzer with a stago reagent.The meter result was >8.0 inr at 7:24 am.The patient's warfarin was withheld for 2 days based on the meter result.No harm was caused to the patient by withholding warfarin.The patient is now on a lower dose of warfarin than she was at the time of the event.The laboratory result was 5.0 inr, and was taken within 1.5 hours of the meter result.The patient's therapeutic range is 2.0 to 3.0 inr.The patient used to test once every 3 weeks, but now tests more frequently due to recent results.
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