BREATHTEK UBT COLLECTION KIT

Description of Event or Problem

PATIENT VOMITED AFTER INGESTING THE PRANACTIN -CITRIC SOLUTION. PRANACTIN-CITRIC IS THE DRUG COMPONENT OF THE BREATHTEK UREA BREATH TEST FOR H. PYLORI INFECTION. TEST WAS ADMINISTERED FOR POST TREATMENT MONITORING OF H. PYLORI INFECTION.

Additional Manufacturer Narrative

MERETEK CONTRACTS OUT THE MANUFACTURE OF THE BREATHTEK UBT COLLECTION KIT, WHICH OCCURS IN THREE SEPARATE PHASES: PHASE I - MANUFACTURE OF THE BULK GRANULATED PRANACTIN-CITRIC DRUG COMPONENT. THIS PART OF THE MANUFACTURE IS PERFORMED BY VPS CORPORATION. PHASE II - PACKAGING THE BULK PRANACTIN-CITRIC DRUG COMPONENT INTO POUCHES. THIS PART OF THE MANUFACTURE IS PERFORMED BY CARDINAL HEALTH. PHASE III - ASSEMBLY OF THE KIT COMPONENTS INTO THE BREATHTEK UBT COLLECTION KIT. THIS ASSEMBLY IS PERFORMED BY DISTRIBUTOR. THE FINISHED BREATHTEK UBT COLLECTION KITS ARE DISTRIBUTED TO MERETEK DIAGNOSTICS, INC. CLIENTS.