BREATHTEK (UBT)

Additional Manufacturer Narrative

THE PATIENT DECLINED FURTHER INFORMATION FOR THE SAFETY REPORT INCLUDING FOLLOW-UP, CONCOMITANT MEDICATIONS AND PROVIDER INFORMATION.

Description of Event or Problem

CASE DESCRIPTION: A (B)(6) FEMALE CONSUMER REPORTED TAKING AN UNKNOWN DOSE OF THE PRANACTIN-CITRIC (13C-UREA) SOLUTION ON (B)(6) 2011, FOR THE PURPOSE OF COMPLETING THE BREATHTEK TEST TO CHECK FOR H. PYLORI. THE PATIENT'S MEDICAL HISTORY INCLUDES AN "ATTACK" OR INFECTION OF H. PYLORI IN 2003. IN (B)(6) 2011, HER DOCTOR DREW BLOOD TWO WEEKS PRIOR TO THE BREATHTEK TEST WHICH SHOWED A POSITIVE RESULT. THE PATIENT'S ALSO HAS A HISTORY OF HYPERTENSION. THE PATIENT'S BLOOD PRESSURE WAS 135/75 WHEN PREVIOUSLY TAKING ONLY ONE DOSE OF TOPROL XL DAILY. IN APPROXIMATELY 2003, THE PATIENT HAD AN "ATTACK" OR INFECTION OF H. PYLORI. IN (B)(6) 2011, THE PATIENT'S PHYSICIAN DREW BLOOD TWO WEEKS PRIOR TO THE BREATHTEK TEST WHICH SHOWED A POSITIVE RESULT. THE PATIENT'S RELEVANT CONCOMITANT MEDICATIONS ARE UNKNOWN. IN (B)(6) 2011, A WEEK AFTER TAKING THE BREATHTEK TEST, THE PATIENT'S BLOOD PRESSURE "SPIKED" TO 223/114. THE PATIENT'S DOCTOR INCREASED THE DOSAGE OF TOPROL XL TO ONE IN THE MORNING AND ONE IN THE EVENING. THE PATIENT'S BLOOD PRESSURE WENT DOWN TO 175/80. AS OF (B)(6) 2011, THE PATIENT'S BLOOD PRESSURE WAS STILL HIGHER THAN PRIOR TO TAKING BREATHTEK.