Model Number STRIP, WALGREENSKETONE 50CT #496636 |
Device Problems
Material Discolored (1170); No Device Output (1435)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/19/2023 |
Event Type
malfunction
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Event Description
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Consumer reported complaint for the ketone test strips.Customer stated that the ketone test strips were grey in color and that they did not change color when testing.The package had not been open or damaged when received by the customer.The customer has been using the ketone test strips for one month.The customer is using the ketone test strips for a keto diet.The product is not stored according to specification (bathroom).The customer did not have another vial of ketone test strips that had been stored and handled correctly.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.
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Manufacturer Narrative
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Internal report reference number: (b)(4).Ketone test strips were returned for evaluation.Product testing was performed and defect found on returned ketone test strips: physical defect of strips, discolored grey pads.Root cause: rc-061: storage outside specifications.Note: manufacturer contacted customer in several follow-up calls to ensure the replacement products resolved the initial concern - 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 10-jul-2023: h6: updated fda¿s type, findings and conclusions codes.H10: retention testing was performed using ketone test strips from the same lot.Retention strip lot tested within specifications.
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Search Alerts/Recalls
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