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: (B)(4): USER HAD AN INACCURATE REFERENCE. NOTE: MANUFACTURER MADE SEVERAL ATTEMPTS TO CONTACT CUSTOMER TO ENSURE THE INITIAL CONCERN HAS BEEN RESOLVED- UNABLE TO ESTABLISH CONTACT WITH CUSTOMER.

Description of Event or Problem

CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS KETONE TEST STRIPS, STATING THAT THEY WERE NOT CHANGING COLOR. THE PACKAGE WAS NOT OPEN OR DAMAGED WHEN RECEIVED BY THE CUSTOMER. THE CUSTOMER IS USING THE PRODUCT FOR THE FIRST TIME OUT OF THIS PACKAGE. THE CUSTOMER IS USING PROPER TESTING TECHNIQUES. THE CUSTOMER WAS NOT WILLING TO PERFORM A URINE TEST DURING THE CALL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION RELATED TO THE USE OF THE PRODUCT WAS REPORTED.