Model Number STRIP, TT 50CT - NOT FORRETAIL SALE |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/06/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Products were returned and pending qc evaluation.Manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - unable to establish contact with customer at this time.
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Event Description
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Consumer reported complaint for physical defects of strips.The expected fasting blood glucose test result range is undisclosed.The customer did not report symptoms.Medical attention is not reported as a result.The product is stored according to specification in the dining room.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 03/31/2022 and open vial date is (b)(6) 2020.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 02-jul-2020: h6: updated fda's method, result, and conclusion codes.H10: meter was not returned for evaluation.Test strips were returned for evaluation.Defect detected: strips stuck together.H10: most likely underlying root cause: rc-003: other root cause: strips stuck together is due to excessive adhesive.Note: manufacturer contacted customer in a follow-up call to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated he was having high readings.The call was transferred to a ccr and a new case was opened: (b)(4).
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Search Alerts/Recalls
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