MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,consumer report with the FDA on 2012-08-30 for BREATHTEK UBT KIT manufactured by Otsuka Pharmaceutical Development And Commercializ.
[15507282]
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.
Patient Sequence No: 1, Text Type: D, B5
[15753762]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3000718406-2012-00004 |
| MDR Report Key | 2722033 |
| Report Source | 04,CONSUMER |
| Date Received | 2012-08-30 |
| Date of Report | 2017-10-31 |
| Date of Event | 2012-07-30 |
| Date Mfgr Received | 2017-09-24 |
| Date Added to Maude | 2012-09-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MIRZA RAHMAN |
| Manufacturer Street | 508 CARNEGIE CENTER DRIVE SUITE 500 |
| Manufacturer City | PRINCETON NJ 085400000 |
| Manufacturer Country | US |
| Manufacturer Postal | 085400000 |
| Manufacturer G1 | OTSUKA AMERICA PHARMACEUTICAL INC |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHTEK UBT KIT |
| Generic Name | UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE |
| Product Code | MSQ |
| Date Received | 2012-08-30 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZ |
| Manufacturer Address | 508 CARNEGIE CENTER DRIVE PRINCETON NJ 08540 US 08540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2012-08-30 |