The patient's product was replaced.The related retention test strips were tested in comparison to masterlot #286321-80 on internal reference meters.For this purpose, two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.The corresponding retention material complies with the specification, based on requirements of the regularly retention testing process of the qc department.The complained test strips have been calibrated against the who standard and are in scope of the roche initiated recall.For these test strips there is a potential for a product problem when the inr is > 4.5.Values > 4.5 inr showed an increasing positive bias.The information in the case is consistent with the details of the recall and the issue has been fully investigated.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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The initial reporter stated one patient received discrepant results when testing with a coaguchek inrange meter (serial number unknown).On (b)(6) 2019, a sample from the patient was tested in the laboratory using the stago neoptimal method, resulting with a value of 3.7 inr.Within 3 hours, a sample from the patient was tested using the meter, resulting with a value of 5.1 inr.On (b)(6) 2019, a sample from the patient was tested in the laboratory using the stago neoptimal method, resulting with a value of 3.9 inr.Within 3 hours, a sample from the patient was tested using the meter, resulting with a value of 5.6 inr.On (b)(6) 2019, a sample from the patient was tested in the laboratory using the stago neoptimal method, resulting with a value of 3.9 inr.Within 3 hours, a sample from the patient was tested using the meter, resulting with a value of 5.6 inr.
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