On (b)(6) 2019, the reporter contacted lifescan (b)(4), alleging that the subject meter read inaccurately high compared to a laboratory device.The reporter claimed obtaining blood glucose readings of ¿285 mg/dl¿ with the subject meter and ¿191 mg/dl¿ on the laboratory device.The tests were performed within 10-30 minutes of each other.Between the tests there was no intervention that would be expected to change the blood glucose.Based on statistical methodology, the calculated difference of these glucose results exceeds lifescan¿s criteria for accuracy.This complaint is being reported because the reported issue was not resolved with troubleshooting.There is no indication that the product caused or contributed to an adverse event.
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