KETONE

Description of Event or Problem

CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS KETONE TEST STRIPS. COMPLAINT WAS REPORTED BY E-MAIL. CUSTOMER STATED THAT THE COLOR ON THE VIAL LABEL WAS WEARING OFF. CUSTOMER WAS CONTACTED VIA TELEPHONE ON (B)(6) 2024; CUSTOMER STATED THAT SHE DISCARDED THE KETONE TEST STRIPS AND WAS UNABLE TO PROVIDE LOT INFORMATION. THE PRODUCT WAS NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). CUSTOMER STATED THAT THE COLOR ON THE VIAL STARTED TO WEAR OFF AND SHE HAD TO PUT CLEAR SCOTCH TAPE ON THE VIAL IN ORDER TO PREVENT IT FROM WARING OFF AND FOR HER TO SEE THE CHART.

Additional Manufacturer Narrative

INTERNAL REPORT REFERENCE NUMBER: 157988-1. KETONE TEST STRIPS WERE NOT RETURNED FOR EVALUATION. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4): THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC. NOTE 1: MANUFACTURER CONTACTED CUSTOMER IN SEVERAL FOLLOW-UP CALLS TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN - UNABLE TO ESTABLISH CONTACT WITH CUSTOMER AT THIS TIME. NOTE 2: MANUFACTURER ACKNOWLEDGES THE LATENESS OF THIS REPORT AND HAS INITIATED THE NECESSARY ACTION: NCN-24-029.