Model Number KETONE STRIPS |
Device Problem
Display Difficult to Read (1181)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(manufacturer narrative = t, corrected data = f) internal report: # (b)(4).Product 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 that the replacement products resolved the initial concern - able to establish contact with customer who indicated he has not use product and he will call back if he has any questions.
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Event Description
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Consumer reported complaint for discoloration of ketone strips (discolored grey).Dad is calling on behalf of his son.The customer is concerned with tests results from results obtained of grey discoloration of ketone strips after use.The customer did not report symptoms.Medical attention is not reported as a result.The product storage location is undisclosed.The test ketone lot manufacturer's expiration date is 01/18/2020 and open vial date is undisclosed.
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Search Alerts/Recalls
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