Model Number KETONE STRIPS |
Device Problem
Ambient Temperature Problem (2878)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/23/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(manufacturer narrative = t, corrected data = f) internal report: # (b)(4).Product returned for evaluation.Most likely underlying root cause: discoloration of test pad due to improper 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 that the replacement ketocare strips working fine.Note: manufacturer reviewed and updated the risk analysis report for the ketone strips on march 2019.Customer complaints for open vial 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 6 of 9.
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Event Description
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Customer called in to report that her ketone strip bottle was open.She purchased two bottles of ketone strips at the pharmacy and states that one of the bottles were open and the strips were a different color.No adverse event or medical intervention was reported.
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Event Description
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Customer called in to report that her ketone strip bottle was open.She purchased two bottles of ketone strips at the pharmacy and states that one of the bottles were open and the strips were a different color.No adverse event or medical intervention was reported.
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Manufacturer Narrative
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(manufacturer narrative = t, corrected data = t) internal report: # (b)(4).Product returned for evaluation.Update: root cause (rc): rc-061: storage outside specifications.Note 1: 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 that the replacement ketocare strips working fine.Note 2: manufacturer reviewed and updated the risk analysis report for the ketone strips on march 2019.Customer complaints for open vial 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 6 of 9.
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Search Alerts/Recalls
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