Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 157, 150, 136 and 146 mg/dl.The customer¿s expected fasting blood glucose test result range is 90-110 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call, a back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer¿s expiration date is 04/20/2023 and open vial date is 11/06/2022.The meter memory was reviewed for previous test result history: result 1: 157 mg/dl, date: (b)(6) 2022, time: 9:30 am , fasting.Result 2: 150 mg/dl, date: (b)(6) 2022, time: 10:24 am, fasting.Result 3: 100 mg/dl, date: (b)(6) 2022, time: 1:35 pm, fasting.Result 4: 136 mg/dl, date: (b)(6) 2022, time: 12:11 pm, fasting.Result 5: 146 mg/dl, date: (b)(6) 2022, time: 11:40 am, fasting.
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Sections with additional information as of 12-jan-2023: h6: updated fda¿s type, findings and conclusions codes.H10: test strips were not returned for evaluation - customer had returned only one test strip, unable to test.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.
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