Model Number STRIP, WALGREENS 100CTTT #673261 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Meter and test strips (2 vials) were returned - product evaluation in-process.Manufacturer contacted customer in a follow-up call on 02-mar-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 physical defect of test strips.Customer stated that the test strips are stuck together.Customer stated that she purchased two vials of test strips on (b)(6) 2022 (same lot number); only one of the vials has been opened by the customer.Customer stated that the test strips that were sticking do not work.The test strip lot manufacturer¿s expiration date is 07/31/2023.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.
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Manufacturer Narrative
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Sections with additional information as of 08-april-2022 h6: updated fda's type of investigation, investigation findings, and investigation conclusions.H10: meter and test strips (2 vials) were returned -defect found on returned strips: physical defects of strips- strips stuck together and control results out of range.Reported defect not reproduced on returned meter.Product evaluation has been completed.Returned product was forwarded to r&d chemistry for root-cause.R&d investigation has been completed root causes selected.Retention strips tested within 6 months passed within specifications.Root cause: rc-003: other root cause: (excess of adhesive on the strips) and rc-061: storage outside specifications.
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Search Alerts/Recalls
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