ID KIT TWO

Description of Event or Problem

ON (B)(6) 2026, CUSTOMER CONTACTED TECHNICAL SERVICE AND REPORTED PATIENT HAD A REACTION TO DRINK PREPARED FOR BREATHID TEST. AFTER INGESTING THE DRINK FOR THE BREATHID TEST, PATIENT EXPERIENCED FACIAL DROOPING AND NUMBNESS IN THE FACE. AT THE TIME OF THE CALL, PATIENT WAS BEING TREATED IN THE EMERGENCY DEPARTMENT OF THE HOSPITAL. TS PROVIDED CUSTOMER WITH SDS, PACKAGE INSERT, AND INGREDIENT LIST OF UREA C13 TABLET AND CITRIC ACID SACHET. ON MAY 4, 2026, ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER. THE PATIENT'S SYMPTOMS BEGAN LESS THAN 15 MINUTES AFTER INGESTING THE BREATHID DRINK. IMMEDIATELY AFTER ONSET OF SYMPTOMS, PATIENT WAS TAKEN TO THE HOSPITAL'S EMERGENCY DEPARTMENT (ED). ED STAFF SUSPECTED ALLERGIC REACTION, AS PATIENT'S TONGUE WAS SWOLLEN. PATIENT WAS TREATED FOR ALLERGIC REACTION SYMPTOMS, AND WAS FEELING BETTER AFTER TREATMENT. CUSTOMER DISCLOSED THAT PATIENT HAD A HISTORY OF FAINTING PRIOR TO THE REACTION TO THE BREATHID DRINK. TECHNICAL SERVICE CONTACTED THE CUSTOMER ON (B)(6) 2026 TO REQUEST RELEVANT PATIENT MEDICAL HISTORY (IF THE CUSTOMER CAN PROVIDE ANY RELEVANT PATIENT MEDICAL HISTORY INCLUDING ALLERGIES, PRIOR REACTIONS, OR NEUROLOGICAL CONDITIONS, IF THE PATIENT HAS ANY KNOWN FOOD OR DRUG SENSITIVITIES, AND REQUESTED A LIST OF PATIENT'S CURRENT MEDICATIONS AND ANY RECENT TREATMENTS). ON (B)(6) 2026, THE CUSTOMER RESPONDED THAT THEY WERE NOT AWARE OF ANY FOOD OR DRUG SENSITIVITIES FOR THIS PATIENT. CUSTOMER WAS NOT AWARE OF ANY ALLERGIES, PRIOR REACTIONS, OR NEUROLOGICAL CONDITIONS FOR THIS PATIENT. CUSTOMER DECLINED TO PROVIDE A LIST OF THE PATIENT'S CURRENT MEDICATIONS AND ANY RECENT TREATMENTS. CUSTOMER STATED THEY ARE UNABLE TO PROVIDE ADDITIONAL INFORMATION REGARDING THIS PATIENT. CUSTOMER DECLINED ADDITIONAL FOLLOW UP. WHILE ANAPHYLACTIC REACTION IS A KNOWN ADVERSE EVENT LISTED IN THE PACKAGE INSERT FOR THE BREATHID KIT TWO, MERIDIAN BIOSCIENCE ISRAEL HAS ELECTED TO SUBMIT AN MDR OUT OF AN ABUNDANCE OF CAUTION.