Model Number STRIP, WGN TMX 60CT 12/CASE MG/DL |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problems
Anxiety (2328); Insufficient Information (4580)
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Event Date 10/18/2022 |
Event Type
Injury
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Event Description
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Consumer reported complaint for error message (e-2).The test strip lot manufacturer¿s expiration date is 01/31/2024 and open vial date is 10/12/2022.The product is not stored according to specification (kitchen).The customer did have another vial of test strips, same lot number, that had been stored and handled correctly.During the call, back to back blood tests were performed by the customer and produced e-5 and e-0 errors using true metrix meter.The customer feels well and did not report any symptoms.Customer stated that he had gone to the er on (b)(6) 2022 because he was not feeling well.Customer was not sure if was due to his diabetes or because he was feeling anxious, and because the meter was not reading his glucose.Customer stated that at the er his glucose was 170 mg/dl non fasting.Customer was released same day and was advised to follow up with his doctor.
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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.Most likely underlying root cause: mlc-020: user's test strip had poor storage.Note: manufacturer contacted customer in several follow-up calls to ensure the initial concern is resolved - 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 02-dec-2022: 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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