(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Ketone strips were returned for evaluation.No defect was detected.Most likely underlying root cause: mlc-20: user's test strip had poor storage 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 4 of 14.
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Customer initially called for assistance in performing ketone test.After performing ketone test, customer stated that test strips were not responding with any of the colors on the color chart and stated the results obtained from multiple strips are all gray-brown in color.Customer stated she is closing the lid immediately after removing each ketone strip from the container.Customer was firmly holding end farthest away from test pad.Customer passed test pad through urine stream.After 15 seconds, the color response was a gray-brown.Customer is storing strips in bathroom and was informed of proper storage locations.Customer opened the ketone strips on 02/20/2018.No adverse event or medical intervention was reported.
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