Model Number STRIP, WALGREENSKETONE 50CT #496636 |
Device Problem
Material Discolored (1170)
|
Patient Problems
Fatigue (1849); Nausea (1970); Vomiting (2144)
|
Event Date 07/02/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: tired, nausea.Ketone test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and to ensure the customer¿s initial concern was resolved - unable to establish contact with customer at this time.
|
|
Event Description
|
Consumer reported complaint of the ketone test strips color not matching the chart on vial after use.This was the first time the customer was using the product out of the package.Customer stated she had been vomiting earlier that morning.Customer stated she had gone to purchase the ketone test strips, had performed a test, but the test strip had turned brown; the color did not match the chart on the vial.At the time of the call the customer reported symptoms of nausea and tired.Customer stated that she was going to seek medical intervention due to the symptoms.
|
|
Manufacturer Narrative
|
Sections with additional information as of 31-aug-2021: h6: updated fda¿s type, findings and conclusions codes.H10: ketone test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-061: improper use/mishandle by end user.
|
|
Search Alerts/Recalls
|