MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2014-10-08 for BREATHTEK UBT KIT manufactured by Otsuka Pharmaceutical Development And Commercializ.
[20015318]
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.
Patient Sequence No: 1, Text Type: D, B5
[20258852]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3000718406-2014-00002 |
| MDR Report Key | 4162880 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-10-08 |
| Date of Report | 2017-11-08 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2014-10-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MIRZA RAHMAN |
| Manufacturer Street | 508 CARNEGIE CENTER DRIVE |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer G1 | OTSUKA |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | 2014-10-08 |
| Operator | LAY USER/PATIENT |
| 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. Life Threatening; 2. Other | 2014-10-08 |