MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-26 for BREATHTEK UBT KIT manufactured by Otsuka.
[90547007]
Since a lot number was not available, otsuka provided potential pranactin citric bulk lot numbers ck3bp03a02, cl3bp03a02, cl3bp03a03, cl3bp03a04, cd4bp03a07, cd4bp03a08, cd4bp03a09, cd4bp03a11, cd4bp03a13, and cf4bp03a02 to cmic for the investigation into the bulk pranactin citric. All the batch records were re-reviewed by cmic and no deviations or anomalies were noted for all the batches. All batches manufactured at cmic cmo usa corporation are made and tested as per cgmp. The bulk products were tested for id at cmic and the finished product is tested and released by otsuka upon meeting product specification and then shipped to customer's packaging site. There have been no process changes or changes deemed to impact processing sharp packaging solutions, the pouch filler: since a lot number was not available, otsuka provided potential pranactin citric pouch lot numbers 170, 173, 174, 175, 176, 177, 178, 179, 181, and 182 to sharp packaging solution to evaluate the pranactin citric pouches. A review of the packaging record for lot size and packaging date, noted issues found during packaging and in-process quality inspections was performed for the aforementioned potential pranactin pouch lot numbers. No issues were noted during any of the quality in-process inspections and associated packaging records and all cleans were found acceptable. There were no related investigation reports for pranactin.
Patient Sequence No: 1, Text Type: N, H10
[90547008]
Event verbatim [preferred term] miscarriage [abortion spontaneous] ,. Case narrative:on (b)(6) 2014, this consumer reported a possible drug exposure during pregnancy. This currently pregnant female consumer of unknown age started pranactic-citric, 1 dose, once, on (b)(6) 2014 for a "chronic sore throat. " the patient? S relevant medical history, concomitant medications, and past drug history were unknown. She had taken 1 dose of pranactin-citric on (b)(6) 2014 and stated "i just found out that i am pregnant. " it was unknown if the consumer was pregnant when she received breathtek. It was unknown if there was any relevant laboratory data. As of (b)(6) 2014, she was not currently scheduled to take another breathtek test. The outcome of possible drug exposure during pregnancy was unknown. Lot and expiration date unknown. Follow-up received from physician on 11-feb-2014: this (b)(6) female patient (date of birth: (b)(6) ) took pranactin-citric for the breathtek test on (b)(6) 2014 and about 2 days later found that she was pregnant (as previously reported). On (b)(6) 2014 the mother had a basic prenatal profile including a test for sexually transmitted diseases which was negative, and a complete blood count with normal results (nos). On an unknown date in 2014, the mother had an ultrasound which was appropriate for a 6 week pregnancy. The mother's medical history: anxiety and having a healthy baby before. The mother's concomitant medication: vitamins, but no prescription medications. As of (b)(6) 2014 the mother was not on pranactin-citric and there were no concerns about the pregnancy at this time. Product quality complaint follow-up received 03mar2015: on (b)(6) 2014, a pregnant female consumer reported a possible drug exposure during pregnancy. The pregnant female consumer of unknown age started pranactin-citric, 1 dose, once, on (b)(6) 2014 for a "chronic sore throat. " she had taken 1 dose of pranactin-citric on (b)(6) 2014 and stated "i just found out that i am pregnant. " it was unknown if the consumer was pregnant when she received breathtek. It was unknown if there was any relevant laboratory data. It was reported in this case that as of (b)(6) 2014, she was not currently scheduled to take another breathtek test. The outcome of possible drug exposure during pregnancy was unknown. Lot and expiration date unknown. It was also noted that a follow-up was received from physician on (b)(6) 2014 with the following statement:? This (b)(6) female patient (date of birth: (b)(6) took pranactin-citric for the breathtek test on (b)(6) 2014 and about 2 days later found that she was pregnant (as previously reported). On (b)(6) 2014 the mother had a basic prenatal profile including a test for sexually transmitted diseases which was negative, and a complete blood count with normal results (nos). On an unknown date in 2014, the mother had an ultrasound which was appropriate for a 6 week pregnancy. The mother's medical history: anxiety and having a healthy baby before. The mother's concomitant medication: vitamins, but no prescription medications?. Furthermore, the following was also noted in this case:? As of (b)(6) 2014 the mother was not on pranactin-citric and there were no concerns about the pregnancy at this time?. This case also noted that there was no adverse event. The root cause of the reported issue is? Documentation failure? (no information available) regarding the prescribing information. The complaint is confirmed. This case was forwarded at the time it was received to cs&pv for safety review and assigned argus number us-2014-10138. Based on the product quality complaint investigation results, the root cause of the complaint is "documentation failure" 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. This report will be forwarded to safety (cs&pv). This reported issue will be sent to the design project team as part of the monthly reconciliation process. The product quality complaint was closed. Follow-up received 16mar2015: a follow-up call was made to the patient. The patient stated that she experienced miscarriage after taking breathtek test. The patient declined to provide further details about the incident and refused further contact. Otsuka causaltiy statement: this case has limited information. From the chronology provided the patient had a single exposure to the drug (breathtek) while pregnant on (b)(6) 2014. Approximately three weeks later the history notes that there were no concerns about the pregnancy, and an ultrasound was done at an unknown date which was approprite for a six week pregnancy. Given the single dose of exposure and continuation of pregnancy for at least 3 more weeks post-exposure it is unlikely that breathtek was causally related to the event of spontaneous abortion. Having said that, the spontaneous reporting implies causality. Otsuka causality assessment: the event is related to the drug because of implied causality due to spontaneous reporting. Follow-up received on 01-may-2015: product quality investigation completed (track wise # 26175): brief description: pranactin-citric (13c-urea) granules us14-002989 - miscarriage (historical case follow up). Since a lot number was not available, otsuka provided potential pranactin citric bulk lot numbers ck3bp03a02, cl3bp03a02, cl3bp03a03, cl3bp03a04, cd4bp03a07, cd4bp03a08, cd4bp03a09, cd4bp03a11, cd4bp03a13, and cf4bp03a02 to cmic for the investigation into the bulk pranactin citric. All the batch records were re-reviewed by cmic and no deviations or anomalies were noted for all the batches. All batches manufactured at cmic cmo usa corporation are made and tested as per cgmp. The bulk products were tested for id at cmic and the finished product is tested and released by otsuka upon meeting product specification and then shipped to customer's packaging site. There have been no process changes or changes deemed to impact processing sharp packaging solutions, the pouch filler: since a lot number was not available, otsuka provided potential pranactin citric pouch lot numbers 170, 173, 174, 175, 176, 177, 178, 179, 181, and 182 to sharp packaging solution to evaluate the pranactin citric pouches. A review of the packaging record for lot size and packaging date, noted issues found during packaging and in-process quality inspections was performed for the aforementioned potential pranactin pouch lot numbers. No issues were noted during any of the quality in-process inspections and associated packaging records and all cleans were found acceptable. Trend analysis: as of 07-apr-2015, a query of the trackwise database for this product and complaint category indicated that this was the only complaint in the system in which a patient had experienced a miscarriage. Based on the investigation results it is determined that the potential pranactin citric bulk and pouched lots involved in this complaint have no manufacturing or quality related issues that could have contributed to the adverse event complaint. Based on the product quality investigation results, the root cause is? Undetermined? ; therefore, the complaint cannot be confirmed and the product has no negative impact. 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 product quality complaint investigation was closed. No additional information is expected. Otsuka causality assessment: this case has limited information. From the chronology provided the patient had a single exposure to the drug (breathtek) while pregnant on (b)(6) 2014. Approximately three weeks later the history notes that there were no concerns about the pregnancy, and an ultrasound was done at an unknown date which was approprite for a six week pregnancy. Given the single dose of exposure and continuation of pregnancy for at least 3 more weeks post-exposure it is unlikely that breathtek was causally related to the event of spontaneous abortion. Having said that, the spontaneous reporting implies causality. Otsuka causality assessment: the event is related to the drug because of implied causality due to spontaneous report. Based on pqc investigation the root cause is undetermined. The case remains reportable secondary to medical review and mdr decision tree. Follow up 04-dec-2016: upon internal review, it was determined that the case j201502414 was duplicate of the case us-2014-10138. All information from the case j201502414 was merged into the case us-2014-10138 and the case j201502414 will be deactivated from the database. Otsuka does not consider the information contained in this individual case safety report to justify any change to the benefit-risk balance of breathtek ubt kit or to justify any safety measures. The fda confirmed that the correct manufacturer report # (mfr #) for this case should be 3000718406-2015-00007. This report and all further follow-ups for this case will be re-submitted under the corrected mfr #. , comment: not provided
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000718406-2015-00007 |
| MDR Report Key | 6979447 |
| Date Received | 2017-10-26 |
| Date of Report | 2014-01-22 |
| Date Added to Maude | 2017-10-26 |
| 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 | 1 UNIVERSITY SQUARE DRIVE, SUITE 500 |
| Manufacturer City | PRINCETON NJ 08540 |
| Manufacturer Country | US |
| Manufacturer Postal | 08540 |
| Manufacturer Phone | 6095359429 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BREATHTEK UBT KIT |
| Generic Name | UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE |
| Product Code | OZA |
| Date Received | 2017-10-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OTSUKA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-26 |