KETONE

Additional Manufacturer Narrative

INTERNAL REPORT REFERENCE NUMBER: (B)(4). 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-020: USER'S TEST STRIP HAD POOR STORAGE. 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 BY E-MAIL AND CUSTOMER WAS CONTACTED VIA TELEPHONE. THE CUSTOMER REPORTED COMPLAINT FOR PHYSICAL DEFECT OF TEST STRIPS. CUSTOMER STATED THAT SHE HAD PURCHASED THE KETONE TEST STRIPS A FEW WEEKS PRIOR AND WAS JUST USING THEM FOR THE FIRST TIME TODAY. CUSTOMER STATED WHEN SHE OPENED THE VIAL THE TEST STRIPS LOOKED NORMAL COLOR, BUT WHEN SHE USED THEM- THEY TURNED BROWN. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS AND MEDICAL ATTENTION RELATED TO THE USE OF THE PRODUCT WAS NOT REPORTED.