The patient called stating that her coaguchek xs meter serial number (b)(4) was reporting values in % quick units.With help from technical service personnel, the patient was able to program the meter correctly.Upon review of the meter memory, erroneous values were observed.Each value was measured with a different test strip lot number.Please refer to the medwatches with the following patient identifiers for information related to each affected test strip lot number: (b)(6) = lot 27216321; (b)(6) = lot 27216421.At 8:42 a.M., a sample from the patient was tested on the meter using test strip lot number 27216321, resulting as 4.8 inr.At 8:46 a.M., a sample from the patient was tested on the meter using test strip lot number 27216421, resulting as 3.0 inr.No adverse events were alleged to have occurred with the patient.The patient did not report the meter results to a doctor, so the patient did not receive treatment or changes in medication.The patient's therapeutic range is 2.0 - 3.0 inr.The patient's testing frequency is once per week.The patient is not anemic or polycythemic.The patient does not have antiphospholipid antibodies.The patient does not take heparin, lovenox, or thrombin inhibitors.The patient has not had changes in diet.The patient did not have a special or unusual diet.The patient does not have bruising or bleeding.The patient's product was requested for investigation and replacement product was sent to the patient.Relevant retention test strips (lot 272163) were tested in comparison with the current master lot.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.
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