BREATHTEK

Additional Manufacturer Narrative

FOLLOW-UP INFORMATION RECEIVED ON (B)(6)2015: THE PQC INVESTIGATION CLOSED RECORD WAS RECEIVED ((B)(4)). THE SUMMARY WAS AS FOLLOWS. THE COMPLAINT SAMPLE WAS NOT AVAILABLE FOR THE SUBJECT COMPLAINT. THEREFORE, AN EVALUATION OF COMPLAINT SAMPLE COULD NOT BE PERFORMED. ADDITIONALLY, A LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE BATCH RECORD COULD NOT BE PERFORMED AND RETAIN SAMPLES COULD NOT BE EVALUATED. THE REPORTED ISSUE WAS RECEIVED BY THE MANUFACTURER ON (B)(4)2013. STABILITY DATA FOR THE PREVIOUS YEAR OF THE RECEIVED DATE, THE YEAR RECEIVED AND THE SUBSEQUENT YEAR WERE REVIEWED. THE STABILITY DATA EVALUATION SHOWED PRANACTIN-CITRIC CONTINUES TO BE WITHIN THE ESTABLISHED SPECIFICATIONS. BASED ON THE PRODUCT QUALITY COMPLAINT INVESTIGATION RESULTS, THE ROOT CAUSE OF THE COMPLAINT WAS "UNDETERMINED" AND THERE WAS NO REPORTED DEVICE MALFUNCTION. THIS REPORT FROM PQC PERSPECTIVE DOES NOT MEET THE REQUIREMENT FOR MDR REPORTABILITY. GMP CONTROLS ARE IN PLACE TO ENSURE THE QUALITY, SAFETY, PURITY, AND EFFICACY OF THE BREATHTEK UBT PRODUCT. THE COMPLAINT WAS NOT CONFIRMED. HOWEVER, THE SEVERITY WAS NOT CHANGED FROM MAJOR TO MINOR DUE TO THE NATURE OF THE REPORTED ALLERGIC REACTION. ON REVIEW OF THE PREVIOUS INFORMATION DATED (B)(6) 2013 AND (B)(6) 2013, THIS CASE IS RE-ASSESSED AS REPORTABLE. IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT INGESTED PREPARATION AT DOCTOR'S OFFICE FOR H.PYLORI BREATH TEST AND WITHIN A MINUTE DEVELOPED REDNESS, RASH, ALLERGIC REACTION, WITH HYPERVENTILATION AND TINGLING. THE PATIENT WAS SENT TO THE ER VIA EMS ON THE SAME DAY. OTSUKAS CAUSALITY ASSESSMENT OF "ALLERGIC REACTION" REPORTED IN THIS PATIENT WAS CONFOUNDED BY HER MEDICAL HISTORY OF DUMPING SYNDROME, GASTRIC BYPASS, AND MULTIPLE GERD SURGERIES. ON (B)(6) 2015, CASE REVIEWED AND BASED ON THE PRESENTING EVENTS, THE ER RECORD AND TEMPORAL RELATIONSHIP TO THE EVENT THE OTSUKA COMPANY ASSESSMENT IS REVISED: THE EVENT OF HYPERSENSITIVITY IS RELATED TO BREATHTEK. EVALUATION SUMMARY BASED ON THE PRODUCT QUALITY COMPLAINT INVESTIGATION RESULTS, THE ROOT CAUSE OF THE COMPLAINT IS "UNDETERMINED" AND THERE IS NO REPORTED DEVICE MALFUNCTION. THIS REPORT FROM PQC PERSPECTIVE DOES NOT MEET THE REQUIREMENT FOR MDR REPORTABILITY. THE COMPLAINT TYPE IS COMPLAINT AND AE. THE COMPLAINT IS NOT CONFIRMED. HOWEVER, THE SEVERITY WAS NOT CHANGED FROM MAJOR TO MINOR DUE TO THE NATURE OF THE REPORTED ALLERGIC REACTION.

Description of Event or Problem

ALLERGIC REACTION - CASE DESCRIPTION: THIS INITIAL REPORT WAS REPORTED ON (B)(6) 2013 BY PHYSICIAN VIA AN OTSUSKA SALES REP. (B)(6) FEMALE PT STARTED PRANACTIN-CITRIC, 1 DOSE ON AN UNK DATE IN 2013 AS PREPARATION FOR THE BREATHTEK TEST FOR DETECTION OF H.PYLORI. THE PT'S RELEVANT MEDICAL HISTORY INCLUDED GASTRIC BYPASS AND MULTIPLE "GERD" (GASTRO ESOPHAGEAL REFLUX DISORDER) SURGERIES, VARIOUS "GI" (GASTROINTESTINAL) ISSUES, DUMPING SYNDROME, "IBS" (IRRITABLE BOWEL SYNDROME), AND REACTIVE HYPOGLYCEMIA. THE PT'S RELEVANT CONCOMITANT MEDICATIONS AND PAST DRUG HISTORY WERE UNK. ON AN UNKNOWN DATE IN 2013, THE PATIENT RECEIVED THE PRANACTIN-CITRIC AND COMPLETED THE TEST. AFTER AN UNKNOWN LENGTH OF TIME, THE PATIENT EXPERIENCED TACHYCARDIA (66 BEFORE TO 110 AFTER THE TEST), FLUSHED, TINGLING FEELING ALL OVER HER FACE, LIPS MILDLY SWOLLEN, AND INCREASED BLOOD PRESSURE (110/80 BEFORE TO 140/90 AFTER THE TEST). NO "SOB" (SHORTNESS OF BREATH) WAS DETECTED. THE "EMS" WAS CALLED AND THE PATIENT WAS BROUGHT TO AN EMERGENCY ROOM. SHE WAS DISCHARGED FROM THE EMERGENCY ROOM ON AN UNKNOWN DATE. LAB DATA: BLOOD PRESSURE (110/80 PRIOR TO TAKING PRANACTIN-CITRIC AND ELEVATED TO 140/90 AFTER THE PRANACTIN-CITRIC. NO "SOB" (SHORTNESS OF BREATH) WAS DETECTED. THE AMBULANCE WAS CALLED AND THE PATIENT WAS BROUGHT TO AN EMERGENCY ROOM. SHE WAS DISCHARGED FROM THE EMERGENCY ROOM ON AN UNKNOWN DATE. AS OF (B)(6)2013, IT WAS UNKNOWN IF SHE CONTINUED TO TAKE PRANACTIC-CITRIC. THE PHYSICIAN REPORTED THE PATIENT WAS "FINE AFTER THE INCIDENT" AND NO LONGER EXPERIENCED AN ANAPHYLACTIC REACTION DESCRIBED AS TACHYCARDIA, FLUSHED, TINGLING FEELING ALL OVER HER FACE, LIPS MILDLY SWOLLEN, AND INCREASED BLOOD PRESSURE AND WAS NO LONGER IN THE EMERGENCY ROOM. FOLLOW-UP WAS RECEIVED FROM PHYSICIAN ON (B)(6) 2013: ON (B)(6) 2013 (AMENDED FROM UNKNOWN) PATIENT WITH PREVIOUSLY REPORTED EVENTS OF TACHYCARDIA (66 BEFORE TO 110 AFTER THE TEST), FLUSHED, TINGLING FEELING ALL OVER HER FACE, LIPS MILDLY SWOLLEN, INCREASED BLOOD PRESSURE (110/80 BEFORE TO 140/90 AFTER THE TEST) PRESENTED TO EMERGENCY ROOM, WAS DIAGNOSED WITH ALLERGIC REACTION AND THEREFORE, PREVIOUSLY REPORTED EVENTS WERE AMENDED TO ALLERGIC REACTION. SHE ALSO EXPERIENCED ADDITIONAL SYMPTOMS OF REDNESS, RASH AND HYPERVENTILATION. REMEDIAL THERAPIES WITH INTRAVENOUS PUSH OF BENADRYL 50 MG, PEPCID 20MG/2 MAL ND SOLU MEDROL 125MG WAS PROVIDED. OUTCOME OF ALLERGIC REACTION WAS REPORTED AS RECOVERED ON (B)(6) 2013. ADDITIONAL MEDICAL HISTORY: ALLERGY TO BEE STING.