CHOL+GLU TEST STRIPS

Additional Manufacturer Narrative

THE CUSTOMER DID NOT RESPOND TO MULTIPLE FOLLOW-UP ATTEMPTS TO PERFORM RETESTING WITH THEIR PRODUCT. THE CUSTOMER DID NOT RETURN PRODUCT FOR EVALUATION. QC RETENTION WAS TESTED AND MEASURED WITHIN SPECIFICATION. THIS EVENT IS BEING REPORTED TO THE FDA OUT OF AN ABUNDANCE OF CAUTION.

Description of Event or Problem

THE CUSTOMER REPORTED THAT TWO PATIENTS EXPERIENCED HIGH GLUCOSE RECOVERY WHEN TESTING WITH THE PRODUCT. ONE PATIENT REPORTED THAT THE VALUE WAS HIGH BUT IS UNSURE OF THEIR EXPECTED VALUE. THE SECOND PATIENT REPORTED THE VALUE RECEIVED (241 MG/DL) WAS HIGH SO THEY TESTED THEMSELVES ON THEIR CGM THEY WERE WEARING AND RECEIVED 141 MG/DL. THERE WERE NO ALLEGATIONS OF PATIENT/USER HARM.