BREATHTEK UBT KIT
Received Aug 30, 2012 · Event occurred Jul 30, 2012
Report 3000718406-2012-00004 · MDR key 2722033
Device
Generic name
Urea Breath Test (ubt) And Calculation Software
Product problems
- Insufficient Device Problem Information
Patient
71 YR · Female
- Atrial Fibrillation
- Tachycardia
- Tachycardia
- Palpitations
- Palpitations
Narrative
Description of Event or Problem
ATRIAL FIBRILLATION [ATRIAL FIBRILLATION]. PREMATURE VENTRICULAR CONTRACTIONS [VENTRICULAR EXTRASYSTOLES]. RACING HEART [PALPITATIONS]. IRREGULAR HEARTBEAT [HEART RATE IRREGULAR]. CASE DESCRIPTION: THIS IS A SPONTANEOUS CASE REPORTED BY A (B)(6) FEMALE CONSUMER WHO EXPERIENCED ATRIAL FIBRILLATION, PREMATURE VENTRICULAR CONTRACTIONS, 'A RACING HEART' AND IRREGULAR HEARTBEAT AFTER INTAKE OF BREATHTEK (PRANACTIN-CITRIC SOLUTION) TO TEST A BLEEDING ULCER. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED ALLERGIES TO MORPHINE, SOME ANTIBIOTICS, AND LARGE ASPIRINS, AS WELL AS A HISTORY OF ATRIAL FIBRILLATION 1.7%, 2 STENTS FROM A YEAR AGO, AND A PACEMAKER IMPLANT. RELEVANT CONCOMITANT MEDICATIONS INCLUDED ZETIA, PLAVIX, DIGOXIN, WARFARIN, FLECAINIDE, METOPROLOL, CRESTOR, AND ATIVAN. RELEVANT PAST DRUG HISTORY WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT TOOK BREATHTEK (PRANACTIN-CITRIC SOLUTION), ONCE TO TEST FOR A BLEEDING ULCER. ON THE SAME DAY, SHE EXPERIENCED ATRIAL FIBRILLATION, PREMATURE VENTRICULAR CONTRACTIONS, IRREGULAR HEARTBEAT, AND A RACING HEART. NO RELEVANT LABORATORY DATA WAS PROVIDED. THE OUTCOME OF THE EVENT WAS UNKNOWN AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS CASE WAS ASSESSED AS SERIOUS (MEDICALLY SIGNIFICANT). OTSUKA'S CAUSALITY ASSESSMENT: THE EVENTS OF ATRIAL FIBRILLATION, PREMATURE VENTRICULAR CONTRACTIONS, RACING HEART IRREGULAR HEART BEAT ARE UNLIKELY RELATED TO PRANACTIN MAY BE POSSIBLY RELATED TO THE ADVANCED AGE OR UNKNOWN UNDERLYING MEDICAL CONDITION. HOWEVER DUE TO TEMPORAL RELATIONSHIP THE CAUSALITY CANNOT BE TOTALLY EXCLUDED.