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Model Number KETONE STRIPS |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Keytone strips were returned for evaluation.Defect was detected.Most likely underlying root cause: rc-061: storage outside specifications note: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern - was able to establish contact with customer who indicated the issue was resolved.Note: manufacturer reviewed and updated the risk analysis report for the ketone strips on march 2019.Customer complaints for open vial and others were reviewed for possible mdr based on internal update of the risk report and the severity of harm, the complaint is reportable, however no adverse event or medical intervention was reported at the time of the call.Complaint 8 of 14.
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Event Description
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Consumer reported complaint for open ketone strips vial.Customer states she opened a sealed box of ketone strips, 100 count on box, 2 bottles of 50 count in each bottle, and one vial had the cap open.No adverse event or medical intervention was reported.
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Search Alerts/Recalls
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