Model Number STRIP, TRUE METRIX 50CTMG/DL |
Device Problem
Low Test Results (2458)
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Patient Problem
Dry Mouth (4485)
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Event Date 11/29/2022 |
Event Type
Injury
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Event Description
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Consumer reported complaint for low blood glucose test results.Mother is calling on behalf of the customer.The customer is concerned with test results from results obtained of 55 and 65 mg/dl am fasting.The customer¿s expected am fasting blood glucose test result range is 80-100 mg/dl.The customer feels well and did not report any symptoms.Mother stated that customer had been experiencing dry mouth when the low results had been obtained.Mother stated customer's doctor had been contacted due to the low results.When the low result of 55 mg/dl had been obtained, the doctor had decreased the long acting insulin dosage.When the result of 65 mg/dl had been obtained, the doctor had recommended a decrease in the dosage of the fast acting insulin.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 12/24/2023 and open vial date is 11/29/2022.The meter memory was not reviewed for previous test result history.
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Manufacturer Narrative
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Internal report reference number: (b)(4).Adverse event report is being submitted due to customer contacting doctor due to meter results.Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-058: user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
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Manufacturer Narrative
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Sections with additional information as of 19-jan-2023: h6: updated fda¿s type, findings and conclusions codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.
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Search Alerts/Recalls
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