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 05/24/2017 |
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.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 is comfortable with results from the replacement strips.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 5 of 9.
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Event Description
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Ketone strips vial was open within a sealed box and all the strips turned 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 is comfortable with results from the replacement strips.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 (b)(4) 5 of (b(4).
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Event Description
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Ketone strips vial was open within a sealed box and all the strips turned color.No adverse event or medical intervention was reported.
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Search Alerts/Recalls
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