Model Number STRIP, CVS 100CT KETONE |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/07/2020 |
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-20: user's test strip had poor storage 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.
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Event Description
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Consumer reported complaint for issues with ketone strip color changes.The customer did not report symptoms.Medical attention is not reported as a result.The product is not stored according to specification and it is stored in the bathroom.During the call, a ketone test was not performed by the customer.The ketone test strip lot manufacturer¿s expiration date is 05/24/2020 and open vial date is undisclosed.
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Manufacturer Narrative
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Sections with additional information as of 03-mar-2020: h6: updated fda's method, result, and conclusion codes.H10: test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested and passed.
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Search Alerts/Recalls
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