As the complaint products were returned, i-sens analyzed the cause of the low readings using the returned meter, strips, and control solution.As a result of the control solution test, all results were within the standard range, and the cv% was within the acceptance criteria (below 5%) which satisfied the internal standard in i-sens.Therefore, it is judged that the product operated normally.
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Meter was purchased and placed into service in (b)(6) 2022.Caller stated they were called on (b)(6) 2022 regarding a patient with diabetic issues.When ems arrived, patient was nearly unconscious.The patient's mother stated that she did not know what led to the patient being in this state and did not know if he had eaten or taken insulin.Caller reported that they did a test with the prism and received a reading of 240.They then started iv therapy to treat patient for possible diabetic ketoacidosis (dka) due to patient's history and signs/symptoms, but the blood glucose readings didn't support the diagnosis.Caller stated they then performed another test with the prism and received a reading of 460.Patient was then transported to the hospital (b)(6) where they tested patient with the nova statstrip glucometer, and they received two consecutive "high" readings.The hospital then tested venous blood and received a glucose level reading of 770.Patient was then treated by the hospital, but the course of their treatment is unknown.Caller stated this was the first time using this device and is concerned that it is not accurate.Replaced meter, strips and sent return label.
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