MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-10-24 for BREATHTEK manufactured by Otsuka Pharmaceutical.
[90086351]
This initial spontaneous report was received from ((b)(6)) on 11-oct-2017. On 11-oct-2017, a mother reported, that a (b)(6) female patient (daughter) started breathtek ubt kit (pranactin citric) on (b)(6) 2017, at full dose, unknown strength, once, orally for the indication of h. Pylori. Relevant medical history included h. Pylori infection, which was treated with three unknown antibiotics and one unknown antacid. The patient did not have any relevant concomitant medication. Laboratory results were unknown. Lot number and expiry date were not provided. On (b)(6) 2017, the daughter consumed the pranactin-citric solution and began vomiting about twenty minutes after drinking it. The daughter also complained about her stomach hurting. The mother reported that the daughter vomited about 23 times on (b)(6) 2017 and about eight times since then. After that she did not vomit as much as before. On the same day, (b)(6) 2017, she also went to the emergency room where she was treated with intravenous (iv) fluids and an unknown medication for nausea. It is unknown, if the patient completed the breathtek test. As of 11-oct-2017, the patient has not consumed the pranactin-citric solution again and her vomiting was improving. Company comment: the events vomiting was assessed as serious (medically significant) and stomach hurting as non-serious. Both the events were assessed as related to breathtek based on temporal association and lack of confounding factors. No further information was available at the time of reporting.
Patient Sequence No: 1, Text Type: D, B5
[184036437]
This follow-up 1 was originally submitted with incorrect report number (3000718-2017-00001) which was later corrected and submitted as follow-up 2. All information from follow-up 1, follow-up 2, and follow-up 3 have been processed and submitted together.
Patient Sequence No: 1, Text Type: N, H10
[184036438]
Event verbatim [preferred term] vomiting [vomiting] , stomach hurts [abdominal pain upper] ,. Case narrative: this initial spontaneous report was received from (b)(4) on (b)(4) 2017. On (b)(4) 2017, a mother reported, that a (b)(6) year-old female patient (daughter) started breathtek ubt kit (pranactin citric) on (b)(6) 2017, at full dose, unknown strength, once, orally for the indication of h. Pylori. Relevant medical history included h. Pylori infection, which was treated with three unknown antibiotics and one unknown antacid. The patient did not have any relevant concomitant medication. Laboratory results were unknown. Lot number and expiry date were not provided. On (b)(6) 2017, the daughter consumed the pranactin-citric solution and began vomiting about twenty minutes after drinking it. The daughter also complained about her stomach hurting. The mother reported that the daughter vomited about 23 times on (b)(6) 2017 and about eight times since then. After that she did not vomit as much as before. On the same day, (b)(6) 2017, she also went to the emergency room where she was treated with intravenous (iv) fluids and an unknown medication for nausea. It is unknown, if the patient completed the breathtek test. As of (b)(6) 2017, the patient has not consumed the pranactin-citric solution again and her vomiting was improving. The outcome of her stomach hurting was unknown. Company comment: the events vomiting was assessed as serious (medically significant) and stomach hurting as non-serious. Both the events were assessed as related to breathtek based on temporal association and lack of confounding factors. No further information was available at the time of reporting. Follow-up was received from the patient's mother by pqc on (b)(6) 2017. The patient's mother stated that her daughter took the breathtek test about a week and a half ago. She began vomiting about twenty minutes after drinking the solution and complained that her stomach was hurting at that time. She vomited many times the day of the test and was very, very sick for the following 3 or 4 days. She vomited a few times more over the next 3 or 4 days immediately after the test, but the condition and issues have improved after that. The patient has not been administered a breathtek test in the past. The patient's mother stated that to her knowledge, the lab did not have any issues with the kit itself or with the administration of the test. The reporter did not know the lot number of the kit and believed the kit was discarded after the test was administered. The outcome of her stomach hurting was unknown and vomiting was improved. (b)(4) causality assessment: : the event vomiting was assessed as serious (medically significant) and stomach hurting as non-serious. Both the events were assessed as related to breathtek based on temporal association. However, underlying condition of h. Pylori infection is a confounding factor. Product quality complaint follow-up received on 12-dec-2017 via closed product quality compliant (pqc) record: batch record review: batch records were reviewed for potential pranactin-citric bulk granulation lot number(s) [ck5bp03a08, ck5bp03a10, ck5bp03a11, ca6bp03a06, ca6bp03a07, ca6bp03a08, cc6bp03a09, cc6bp03a10, cc6bp03a11, cc6bp03a13, cc6bp03a14, cc6bp03a15, and cd6bp03a11] and no manufacturing related deviations, anomalies or observations were noted for this batch. All batches manufactured at cmic cmo usa corporation are made and tested as per cgmp. All batch records were qa reviewed and approved by (b)(4) qa. There have been no process changes or changes deemed to impact processing. The annual product review for this product reporting for 2015 & 2016 reports that all in-process test data were within specifications with no discernible trend. The bulk product was tested for id at cmlc and met the product bulk specification. Desc/evaluation of comp sample: the complaint sample was not available for the subject complaint. Therefore, an evaluation of complaint sample could not be performed. Retain sample evaluation: a lot number was not provided for the subject complaint; therefore retain testing is not required. Opdc-gpq reviewed the current stability data for pranactin-citric. The stability data evaluation showed the product behavior continues to be within the established specifications. Based on the product quality complaint investigation results, the root cause of the complaint is undetermined. (b)(4) causality assessment: : per pqc report, the root cause of the complaint is undetermined. Follow-up information (query answer) received on (b)(6) 2018 by treating physician: patient was not hospitalised. (b)(4) causality assessment: per pqc report, the root cause of the complaint is undetermined. , comment: not applicable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000718406-2017-00003 |
| MDR Report Key | 6972704 |
| Report Source | OTHER |
| Date Received | 2017-10-24 |
| Date of Report | 2017-10-23 |
| Date of Event | 2017-10-07 |
| Date Mfgr Received | 2017-10-11 |
| Date Added to Maude | 2017-10-24 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| 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 |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BREATHTEK |
| Generic Name | UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE |
| Product Code | MSQ |
| Date Received | 2017-10-24 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA PHARMACEUTICAL |
| Manufacturer Address | 508 CARNEGIE CENTER PRINCETON NJ 08540 US 08540 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-24 |