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Model Number STRIP, CVS 100CT KETONE |
Device Problem
Material Discolored (1170)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal report reference number: (b)(4).Ketone test strips were returned for evaluation, defect detected on returned strips, discolored grey pads.Root cause: rc-061: storage outside specifications.Note: manufacturer contacted customer in a follow-up call on 12-nov-2020 to ensure the replacement products resolved the initial concern - able to establish contact with customer and stated replacement product resolved initial concern.
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Event Description
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Consumer reported complaint for physical defect of ketone test strips.Strips were grey in color.The customer first used the product 9 days prior to call.The customer feels well and did not report any symptoms.No medical attention was reported.The product is not stored according to specification, it is stored in the bathroom.Customer had another vial of the same lot number that had been stored and handled correctly; customer did not report that this vial was discolored.The customer was using proper testing technique.
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Search Alerts/Recalls
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