(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Ketone strips were return for evaluation.No defect was detected.Most likely underlying root cause: mlc-1: user had an inaccurate reference.Note: manufacturer contacted customer in a follow-up call to ensure that the replacement products resolved the initial concern -unable to establish contact with customer 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 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 5 of 14.
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