Model Number STRIP, TMX CVS 100CT12/CASE MG/DL |
Device Problem
High Test Results (2457)
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Patient Problems
Headache (1880); Sweating (2444)
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Event Date 12/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in a follow-up call on 17-dec-2021 to ensure the patient condition improved and initial concern is resolved - able to establish contact with customer and stated is the customer's condition had improved and did not currently have any diabetic symptoms.No medical intervention since the last call was reported.
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Event Description
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Consumer reported complaint for hi blood glucose test results.Granddaughter is calling on behalf of the customer.The customer is concerned with test results from results obtained of hi.Granddaughter stated the customer had tested 30 minutes prior to call and had obtained hi.Granddaughter did not know the customer's expected blood glucose test result range.At the time of the call the customer reported sweating and having a headache; medical attention was not needed at the time.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 12/31/2021 and test strips were open two weeks ago.The meter memory was not reviewed for previous test result history.
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Manufacturer Narrative
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Sections with additional information as of 25-feb-2021: h6: updated fda's method, result, and conclusion 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 and passed.Most likely underlying root cause: mlc-018: user has high glucose value.
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Search Alerts/Recalls
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