The customer¿s products have been requested for return.The product has not been received at this time.If the product is returned in the future, a follow-up report will be submitted.Routine retention testing was performed and passed the internal inspection.Retention testing data is reviewed and appropriate actions are taken as needed.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." unique identifier (udi) # (b)(4).Initial reporter occupation was lay user/patient.
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There was an allegation of a questionable result from coaguchek xs meter serial number (b)(4).At 12:25 pm, the result from the meter was 4.6 inr.At 1:20 pm, the result from the laboratory using stago star max using neoplastin reagent was 3.0 inr.The therapeutic range was 2.5-3.5 inr and the patient tests weekly.
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The reporter's meter and test strips were provided for investigation where they were tested using retention controls.Testing results (qc range = 2.1 - 3.3 inr): qc 1: 2.6 inr, qc 2: 2.6 inr, qc 3: 2.6 inr.The obtained qc values were in the allowed range of the used combination strip lot qc lot.All measurements were without error messages.The investigation did not identify a product problem.The cause of the event could not be determined.Medwatch fields d9 and h3 have been updated.
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