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 11/17/2016 |
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.Root cause: black chemistry due to improper storage.Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact at this time.Product notification letter sent to contact customer care.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 3 of 9.
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Event Description
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Customer called in and left message stating she bought ketone strips on (b)(6) 2016 and the vial was already opened when she opened the box.Called customer back, customer states she has 2 vials of ketone strips with the same lot number and does not remember which one was opened.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 #0(b)(4) product returned for evaluation.Update root cause (rc): rc-061: storage outside specifications note 1: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact at this time.Product notification letter sent to contact customer care.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 3 of 9.
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Event Description
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Customer called in and left message stating she bought ketone strips on (b)(6)2016 and the vial was already opened when she opened the box.Called customer back, customer states she has 2 vials of ketone strips with the same lot number and does not remember which one was opened.No adverse event or medical intervention was reported.
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Search Alerts/Recalls
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