Model Number METER, TVH SDK W/VIAL |
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 09/16/2020 |
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.Note: 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.Product notification letter sent to contact customer care.
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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 storage location is undisclosed.During the call a back to back blood test was not performed by the customer.The test strip lot manufacturer¿s expiration date is 01/31/2021 and open vial date is undisclosed.
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Manufacturer Narrative
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Sections with additional information as of 19-nov-2020 h6: updated fda's method, result, and conclusion codes.H10: test strips were returned for evaluation; returned test strips were observed stuck together in a stack and with adhesive.Meter was returned for evaluation; no defect was detected.Most likely underlying root cause: rc-080: excessive adhesive on cover edge caused by slitting process - refer to capa-19-002.Rc-003: other root cause: strips stuck together is due to excessive adhesive.
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Search Alerts/Recalls
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