Model Number STRIP, TMX HNO 50CT24/CS MG/DL |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Meter and test strips were returned - product evaluation in-process.Note: manufacturer contacted customer in a follow-up call on (b)(6) 2022 to ensure the replacement products resolved the initial concern - able to establish contact with customer who stated replacement products resolved initial concern.
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Event Description
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Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 246 and 204 mg/dl.The customer¿s expected fasting blood glucose test result range is 120-140 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.Product storage was not disclosed.The test strip lot manufacturer¿s expiration date is 03/15/2024; customer could not recall the open vial date and was unsure if the test strips had been opened for more than four months.The customer did not have another vial of test strips that had been stored and handled correctly.The meter memory was reviewed for previous test result history: result 1: 254 mg/dl date: on (b)(6) time: 12:14 pm fasting 2-3 hours after breakfast, result 2: 170 mg/dl date: on (b)(6) time: 1:18 pm fasting 2-3 hours after breakfast, result 3: 204 mg/dl date: on (b)(6) time: 7:49 am fasting, result 4: 246 mg/dl date: on (b)(6) time: 7:48 am fasting, result 5: 152 mg/dl date: on (b)(6) time: 11:43 am fasting.
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Manufacturer Narrative
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Sections with additional information as of 19-jan-2023: h3: was the device evaluated by the manufacturer.H6: updated fda¿s type, findings and conclusions codes.H10: meter and test strips (2 vials) were returned for evaluation.Product testing was performed and no defect found.Second returned test strip vial acceptable with lab meters.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-062: user had poor technique.
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Search Alerts/Recalls
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