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 ¿14.8 mmol/l¿ with the subject meter and ¿9.0 mmol/l¿ on the laboratory device.The tests were performed within 10 minutes of each other.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 was no indication that the product caused or contributed to an adverse event.
|