BREATHTEK UBT KIT

Additional Manufacturer Narrative

FOLLOW-UP INFORMATION WAS RECEIVED ON 25-SEPT-2014. PRODUCT INVESTIGATION WAS PERFORMED; RESULT PENDING (B)(4). FOLLOW-UP INFORMATION WAS RECEIVED ON 01-OCT-2014: THE PATIENT WAS ON CHEMOTHERAPY FOR PANCREATIC CANCER. THE REPORTER WANTED TO KNOW IF CHEMOTHERAPY WOULD AFFECT THE RESULT OF THE BREATHTEK TEST. THE REPEAT BREATHTEK TEST WAS NEGATIVE (AFTER ANTIBIOTIC THERAPY FOR A PREVIOUS H. PYLORI TEST). THE PATIENT'S HCP CONTACT INFORMATION WAS PROVIDED. FURTHER INFORMATION WILL BE REQUESTED.

Description of Event or Problem

PANCREATIC CANCER [PANCREATIC CANCER] CASE DESCRIPTION: ON (B)(6) 2014, INFORMATION WAS RECEIVED FROM A MEDICAL ASSISTANT REGARDING A (B)(6) MALE PATIENT WHO RECEIVED ONE DOSE OF PRANACTIN CITRIC (DOSE UNK) ORALLY ON (B)(6) 2014 IN PREPARATION FOR THE BREATHTEK TEST FOR DETECTION OF H. PYLORI WITH A DYSPEPSIA DIAGNOSIS. THE MEDICAL ASSISTANT REPORTED THAT THE PATIENT WAS A HEALTHY MALE AND DID NOT HAVE ANY RELEVANT MEDICAL HISTORY, CONCOMITANT MEDICATION, OR PAST DRUG HISTORY. ON (B)(6) 2014, HE TESTED POSITIVE FOR H. PYLORI AND WAS PRESCRIBED UNKNOWN ANTIBIOTICS TO TREAT THE INFECTION. ON AN UNKNOWN DATE, HE WAS DIAGNOSED WITH PANCREATIC CANCER, STAGE 2 OR 3. HE IS CURRENTLY TAKING UNKNOWN PAIN AND NAUSEA MEDICATIONS, AS WELL AS "GEM" CHEMOTHERAPY AND "PLATINUM" CHEMOTHERAPY, ALL TO TREAT HIS CANCER DIAGNOSIS. HE IS CURRENTLY SCHEDULED TO BE RETESTED WITH PRANACTIN CITRIC TO DETERMINE ERADICATION OF H. PYLORI. AS OF (B)(6) 2014, HE IS SCHEDULED TO RETEST WITH PRANACTIN CITRIC AND CONTINUES TO EXPERIENCE PANCREATIC CANCER. FURTHER INFORMATION WILL BE REQUESTED.