KETONE

Additional Manufacturer Narrative

SECTIONS WITH ADDITIONAL INFORMATION AS OF 06-APR-2026: H3: WAS THE DEVICE EVALUATED BY THE MANUFACTURER. H6: UPDATED FDA¿S TYPE, FINDINGS AND CONCLUSIONS CODES. H10: KETONE TEST STRIPS WERE RETURNED FOR EVALUATION. PRODUCT TESTING WAS PERFORMED AND DEFECT FOUND ON RETURNED KETONE TEST STRIPS: PHYSICAL DEFECT OF STRIPS/MISSING PADS. RETURNED PRODUCT WAS FORWARDED TO PRODUCTION OPERATIONS AND INTERNAL EVALUATION COMPLETED. THE ROOT CAUSE IS ASSOCIATED WITH NCN-25-035. ROOT CAUSE: RC-075: SUPPLIER MANUFACTURING DEFECT.

Additional Manufacturer Narrative

INTERNAL REPORT REFERENCE NUMBER: (B)(4). KETONE TEST STRIPS WERE RETURNED - PRODUCT EVALUATION IN PROCESS. RETENTION TESTING WAS PERFORMED USING TEST STRIPS FROM THE SAME LOT. RETENTION STRIP LOT PASSED WITHIN SPECIFICATIONS. MOST LIKELY UNDERLYING ROOT CAUSE: (B)(4): THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE MLURC NOTE: MANUFACTURER CONTACTED CUSTOMER IN A FOLLOW-UP CALL ON 04-FEB-2026 TO ENSURE THE REPLACEMENT PRODUCTS RESOLVED THE INITIAL CONCERN -ABLE TO ESTABLISH CONTACT WITH CUSTOMER WHO STATED SHE IS NOT INTERESTED AND DECLINED ANY ADDITIONAL ATTEMPTS.

Description of Event or Problem

CONSUMER REPORTED COMPLAINT FOR THE TRUEPLUS KETONE TEST STRIPS. CUSTOMER STATED THAT WHEN SHE OPENED UP THE VIAL OF THE KETONE STRIPS THE PAD ON SOME OF THE STRIPS HAD FALLEN OFF. PER THE CUSTOMER THE PADS FROM SOME OF THE TEST STRIPS WERE AT THE BOTTOM OF THE VIAL. THE CUSTOMER FEELS WELL AND DID NOT REPORT ANY SYMPTOMS. NO MEDICAL ATTENTION ASSOCIATED WITH THE USE OF THE PRODUCT WAS REPORTED. PER THE CUSTOMER THE PACKAGE HAD NOT BEEN OPEN OR DAMAGED WHEN RECEIVED. PER CUSTOMER, THE PRODUCT IS NOT STORED ACCORDING TO SPECIFICATION (BATHROOM). THE TEST STRIP LOT MANUFACTURER¿S EXPIRATION DATE IS 02/24/2027 THE CUSTOMER FIRST USED THE PRODUCT 2 WEEKS AGO. THE CUSTOMER DID NOT HAVE ANOTHER VIAL OF TEST STRIPS THAT HAD BEEN STORED AND HANDLED CORRECTLY.