Model Number STRIP, WALGREENSKETONE 50CT #496636 |
Device Problem
Material Discolored (1170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Ketone test strips were not returned for evaluation.Most likely underlying root cause: mlc-028: there was not enough information to determine the mlurc.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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Event Description
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Consumer reported complaint for the ketone test strips.Customer stated she had purchased the ketone test strips two weeks prior to call.Customer stated that the ketone test strips were grey in color when the vial was opened and they did not change color when testing.Customer stated she had purchased two vials, same lot number; customer stated the issue was with only one of the vials.Customer is using the ketone test strips for the keto diet.The customer feels well and did not report any symptoms.No medical attention associated with the use of the product was reported.Customer declined to perform a test during the call.
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Manufacturer Narrative
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Sections with additional information as of 17-apr-2023: h6: updated fda¿s type, findings and conclusions codes.H10: ketone 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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