KETONE

Additional Manufacturer Narrative

INTERNAL REPORT REFERENCE NUMBER: (B)(4). ADDITIONAL REPORT REFERENCE NUMBER: (B)(4). KETONE TEST STRIPS WERE NOT RETURNED FOR EVALUATION (PER THE CUSTOMER, HAD DISCARDED, NO LOT NUMBER PROVIDED). MOST LIKELY UNDERLYING ROOT CAUSE: MLC-061: IMPROPER USE/MISHANDLED BY END USER. NOTE: 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.

Description of Event or Problem

CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS KETONE TEST STRIPS. COMPLAINT WAS INITIALLY REPORTED VIA E-MAIL AND CUSTOMER CONTACTED MANUFACTURER VIA TELEPHONE. CUSTOMER REPORTED THAT ABOUT 10 OF THE STRIPS IN 2 VIALS OF THE KETONE TEST STRIPS WERE MISSING THE PAD ON THE STRIPS. CUSTOMER ALSO REPORTED THAT IN THE CURRENT VIAL, 2 PADS WERE STUCK TO ONE OF THE TEST STRIPS. PER THE CUSTOMER SHE HAD DISCARDED THE VIAL AND WAS UNABLE TO PROVIDE THE LOT NUMBER. ADDITIONAL REPORT REFERENCE NUMBER (B)(4). THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.