The meter was provided for investigation.Upon investigation, the returned meter failed to power on with fresh retention batteries.Examination of the battery compartment revealed heavy contamination due to a leaked battery.The contamination prevents the meter from powering on.The meter cannot be tested further.The test strips were provided for investigation where they were tested using a retention meter and retention controls.Testing results (qc range = 4.1 - 6.8 inr): qc 1: 5.2 inr, qc 2: 5.0 inr, qc 3: 5.2 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.Occupation was patient/consumer.The initial reporter was the patient's husband.
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There was an allegation of questionable results from coaguchek xs meter serial number (b)(4) and an allegation the patient had a cerebral stroke due to blood clots generated by a st jude valve because the patient's inr was low.On (b)(6) 2021, the patient had double vision and felt dizzy so she was driven to the hospital.Testing on the meter was not performed prior to going to the hospital on this date.The result from the hospital laboratory using an unknown reagent was reportedly 1.0 inr.The patient was reportedly put on lovenox based on this result.A ct (computed tomography) scan was performed which reportedly showed a hemorrhage in the brain, but allegedly no bleeding was found in the brain.When asked about the ct scan findings, the reporter alleged that the doctor suspects that it was a hemorrhage but no blood was detected on the ct scan.On (b)(6) 2021, the patient had an mri and an mra that reportedly showed there were a few small clots located in the narrow lower part of the brain stem.No blood loss was seen.An ultrasound of the heart was performed and the valve evaluation was okay.The patient was hospitalized for a week and because of the stroke, the patient has double vision, tremors in the hand, balance issues, and some speech issues.The patient is reportedly continuing to improve in all areas of recovery.The therapeutic range was 2.5-3.5 inr and the patient tests weekly.This mdr is being submitted in an abundance of caution.
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