On (b)(6) 2018, the reporter contacted lifescan (b)(6), alleging that the subject meter read inaccurately high compared to a laboratory device.The reporter claimed obtaining blood glucose readings of ¿385 mg/dl¿ with the subject meter and ¿180 mg/dl¿ 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.
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The lay user/patients meter have been returned and evaluated by lifescan product analysis with the following findings: the meter passed all testing with no faults found.The reported issue could not be confirmed.Complaints relating to the reported product(s) were evaluated.It was concluded that the number of complaints for the product(s) did not breach thresholds indicative of a systemic issue.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.
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