IDKIT TWO

Description of Event or Problem

CUSTOMER REPORTED THE PATIENT REPORTED FEELING ABDOMINAL PAIN AND BLOATING PRIOR TO THE TEST. CUSTOMER REPORTED THE STAFF PREPARED THE DRINK ACCORDING TO THE INSTRUCTIONS LISTED IN THE PACKAGE INSERT, THEN ADMINISTERED THE DRINK TO THE PATIENT ON WEDNESDAY, (B)(6) 2024. AFTER INGESTING THE DRINK, THE PATIENT REPORTED FEELING DIZZY, NUMB, AND REPORTED STOMACH CRAMPS. THE CUSTOMER REPORTED THE PATIENT MAY HAVE LOST CONSCIOUSNESS BRIEFLY. THE CUSTOMER REPORTED THE PATIENT WENT TO THE HOSPITAL FOR EVALUATION. THE CUSTOMER REPORTED THE PATIENT FELT "FINE" AFTER RECEIVING CARE AT THE HOSPITAL. THE CUSTOMER FOLLOWED UP WITH THE PATIENT ON (B)(6) 2024 AND THE PATIENT REPORTED SHE WAS FEELING WELL. MERIDIAN BIOSCIENCE BECAME AWARE OF THESE EVENTS ON DECEMBER 23, 2024. WHILE THERE IS NO INDICATION THAT THE PERFORMANCE OF OR RESULTS PROVIDED BY THE BREATHID KIT TWO CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITION, MERIDIAN BIOSCIENCE HAS ELECTED TO SUBMIT AN MDR OUT OF AN EXTREME ABUNDANCE OF CAUTION. BOTH SUSPECTED PRODUCTS ARE UNDER INVESTIGATION TO MAKE SURE NO SPECIAL EVENTS WERE REPORTED DURING ITS PRODUCTION.