The customer received error messages and questionable results from coaguchek xs meter serial number (b)(4).The results at 9:15 am, 9:20 am, and at 9:33 am were >8.0 inr.The result at 9:36 am was 5.4 inr.There was no allegation of an adverse event.The therapeutic range was 2.0-3.0 inr.The customer was not anemic, no heparin, no antiphospholipid antibodies, and no direct thrombin inhibitor.The customer had no diet changes, no other illnesses, normal bruising, and no bleeding symptoms.The customer had diarrhea since (b)(6) and was taking imodium.The suspect meter and strips were requested to be returned for investigation.Relevant retention test strips (lot 247896-22) were tested in comparison with the current master lot coaguchek xs pt test strip (lot 124158-80).For this purpose two human blood samples from marcumar donors and two internal reference meters were used.No error messages occurred.Retention samples were acceptable and retention material performed as specified.
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