MAUDE Adverse Event Report: OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZ BREATHTEK UBT KIT; UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

Event 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 unknown) 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 re tested 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.Follow-up information was received on 25-sep-2014 product investigation was performed; result pending (trackwise number (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 patients hcp contact information was provided.Further information will be requested.Follow-up information received 28-jan-2015: the closed report of the product quality complaint investigation was received.The preliminary investigation took longer than 10 day because the potential lot number was not available.The potential lot number was available on 06-nov-2014.As a part of the product quality complaint process, opdc-qm made several attempts to obtain the lot number from the complainant to assist in the investigation.Efforts made to try to obtain a sample or a batch number for this complaint were unsuccessful.Therefore opdc-qm followed up with customer service (cs) to obtain potential lot numbers.Cs provided potential lot numbers for this customer for the past six months.Lot numbers 163k05h, 166k05h, 167k05h, 170k05h, 173k05s, 174k05s and 175k05s were investigated as potential lot numbers.Cmic (the drug manufacture) conducted an investigation on corresponding lot numbers - 163 - cf3bp03a11, 166 -ch3bp03a04, 167 -ch3bp03a06, 170 -ck3bp03a02, 173- cl3bp03a02, 174 - cl3bp03a03, and 175 - cl3bp03a04.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 were made and tested as per cgmp.Sharp packaging solution reviewed the packaging record for lot size, packaging date, and noted issues during packaging and in-process quality inspections.No issues were noted during any of the quality in-process inspection and associated packaging.Based on the investigation conducted by the drug manufacturer and pouch filler, it was determined that pranactin citric had no quality or manufacturing related issues, and that there was no systematic failure, breakdown or procedural condition issue that would likely adversely impact the identity, safety or quality of the product.The root case for this complaint was undetermined and the complaint was not confirmed.An evaluation of mdr reportability for breath tek has been performed.Based on the investigation results, this event is not reportable and does not pose a risk to patients.The hcp declined to offer further information; efforts to obtain follow-up information will be discontinued and the case will be closed.Product quality complaint follow-up received 05-feb-2015: this report was previously submitted under mfg report number 3000718406-2014-0002.This report and all subsequent follow-ups will be submitted under mfg report number 9107159-2015-00001.The preliminary investigation took longer than 10 day due to potential lot number was not available.Potential lot number was available on 06-nov-2014.However each breathtek kit is required to meet specific manufacturing and testing standards prior to release to the market.As a part of the product quality complaint process, opdc-qm makes several attempts to obtain the lot number from the complainant to assist in the investigation.Efforts made to try to obtain a sample/or a batch number for this complaint were unsuccessful.Therefore opdc-qm followed up with customer service (cs) to obtain potential lot numbers.Cs provided potential lot numbers for this customer for the past six months.Lot numbers 163k05h, 166k05h, 167k05h, 170k05h, 173k05s, 174k05s and 175k05s were investigated as potential lot numbers.This complaint was forwarded to the cmic (the drug manufacture) and sharp packaging solutions (pouch filler) to conduct an investigation of the manufacturing, pouch filling operations and record review evaluation.Cmic since a lot number was not available, otsuka provided potential lot numbers 163,166,167,170,173,174 and 175 to cmic to investigation the pranactin citric.Cmic conducted an investigation on corresponding lot numbers - 163 - cf3bp03a11, 166 -ch3bp03a04, 167 -ch3bp03a06, 170 -ck3bp03a02, 173- cl3bp03a02, 174 - cl3bp03a03, 175 - cl3bp03a04.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 solution base on breathtek product genealogy otsuka provided potential lot numbers 163, 164, 166, 167,170, 173, 174 and 175 to sharp packaging solution to evaluate the pranactin citric pouches.A review of the packaging record for lot size, packaging date, and noted issues during packaging and in-process quality inspections was performed by sharp packaging solution.No issues noted.There were no issues noted during any of the quality in-process inspection and associated packaging.There are no issues noted during any of the quality in-process inspections.There are no issues noted in the associated packaging records.All cleans were found acceptable.There are no related investigation reports for pranactin.Based on the investigation conducted by the drug manufacturer and pouch filler it is determined that pranactin citric has no quality or manufacturing related issue.The root case for this complaint is undetermined.Complaint is not confirmed.An evaluation of mdr reportability for breathtek has been performed.Based on the product quality complaint investigation results, this event is not reportable and does not pose a risk to patient.The severity was changed from critical to minor.Based on the investigation from the drug manufacturer and pouch filler, there is no systematic failure, breakdown or procedural condition issue that would likely adversely impact the identity, safety or quality of the product.The product quality complaint was closed.Otsuka causality statement: from medical point of view, it is unlikely that in such a short time, one time use of breathtek kit have caused the event of pancreatic cancer.This case is now being downgraded.Based on mdr reportability decision tree and the pqc investigation result, this case is not mdr reportable.On 14-sep-2017, the fda confirmed that the correct manufacturer report # (mfr #) for this case should be 3000718406-2014-00002.This report and all further follow-ups for this case will be re-submitted under the corrected mfr #.

Event Description

On 09-sep-2014, information was received from a medical assistant regarding a (b)(6) year-old male patient who received one dose of pranactin citric (dose unknown) 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 re tested 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.Follow-up information was received on 25-sep-2014.Product investigation was performed; result pending (trackwise number (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 patients hcp contact information was provided.Further information will be requested.Follow-up information received 28-jan-2015: the closed report of the product quality complaint investigation was received.The preliminary investigation took longer than 10 day because the potential lot number was not available.The potential lot number was available on 06-nov-2014.As a part of the product quality complaint process, opdc-qm made several attempts to obtain the lot number from the complainant to assist in the investigation.Efforts made to try to obtain a sample or a batch number for this complaint were unsuccessful.Therefore opdc-qm followed up with customer service (cs) to obtain potential lot numbers.Cs provided potential lot numbers for this customer for the past six months.Lot numbers 163k05h, 166k05h, 167k05h, 170k05h, 173k05s, 174k05s and 175k05s were investigated as potential lot numbers.Cmic (the drug manufacture) conducted an investigation on corresponding lot numbers - 163 - cf3bp03a11, 166 -ch3bp03a04, 167 -ch3bp03a06, 170 -ck3bp03a02, 173- cl3bp03a02, 174 - cl3bp03a03, and 175 - cl3bp03a04.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 were made and tested as per cgmp.Sharp packaging solution reviewed the packaging record for lot size, packaging date, and noted issues during packaging and in-process quality inspections.No issues were noted during any of the quality in-process inspection and associated packaging.Based on the investigation conducted by the drug manufacturer and pouch filler, it was determined that pranactin citric had no quality or manufacturing related issues, and that there was no systematic failure, breakdown or procedural condition issue that would likely adversely impact the identity, safety or quality of the product.The root case for this complaint was undetermined and the complaint was not confirmed.An evaluation of mdr reportability for breath tek has been performed.Based on the investigation results, this event is not reportable and does not pose a risk to patients.The hcp declined to offer further information; efforts to obtain follow-up information will be discontinued and the case will be closed.Product quality complaint follow-up received 05-feb-2015: this report was previously submitted under mfg report number 3000718406-2014-0002.This report and all subsequent follow-ups will be submitted under mfg report number 9107159-2015-00001.The preliminary investigation took longer than 10 day due to potential lot number was not available.Potential lot number was available on 06-nov-2014.However each breathtek kit is required to meet specific manufacturing and testing standards prior to release to the market.As a part of the product quality complaint process, opdc-qm makes several attempts to obtain the lot number from the complainant to assist in the investigation.Efforts made to try to obtain a sample/or a batch number for this complaint were unsuccessful.Therefore opdc-qm followed up with customer service (cs) to obtain potential lot numbers.Cs provided potential lot numbers for this customer for the past six months.Lot numbers 163k05h, 166k05h, 167k05h, 170k05h, 173k05s, 174k05s and 175k05s were investigated as potential lot numbers.This complaint was forwarded to the cmic (the drug manufacture) and sharp packaging solutions (pouch filler) to conduct an investigation of the manufacturing, pouch filling operations and record review evaluation.Cmic since a lot number was not available, (b)(4) provided potential lot numbers 163,166,167,170,173,174 and 175 to cmic to investigation the pranactin citric.Cmic conducted an investigation on corresponding lot numbers - 163 - cf3bp03a11, 166 -ch3bp03a04, 167 -ch3bp03a06, 170 -ck3bp03a02, 173- cl3bp03a02, 174 - cl3bp03a03, 175 - cl3bp03a04.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 (b)(4) 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 solution base on breathtek product genealogy (b)(4) provided potential lot numbers 163, 164, 166, 167,170, 173, 174 and 175 to sharp packaging solution to evaluate the pranactin citric pouches.A review of the packaging record for lot size, packaging date, and noted issues during packaging and in-process quality inspections was performed by sharp packaging solution.No issues noted.There were no issues noted during any of the quality in-process inspection and associated packaging.There are no issues noted during any of the quality in-process inspections.There are no issues noted in the associated packaging records.All cleans were found acceptable.There are no related investigation reports for pranactin.Based on the investigation conducted by the drug manufacturer and pouch filler it is determined that pranactin citric has no quality or manufacturing related issue.The root case for this complaint is undetermined.Complaint is not confirmed.An evaluation of mdr reportability for breathtek has been performed.Based on the product quality complaint investigation results, this event is not reportable and does not pose a risk to patient.The severity was changed from critical to minor.Based on the investigation from the drug manufacturer and pouch filler, there is no systematic failure, breakdown or procedural condition issue that would likely adversely impact the identity, safety or quality of the product.The product quality complaint was closed.(b)(4) causality statement: from medical point of view, it is unlikely that in such a short time, one time use of breathtek kit have caused the event of pancreatic cancer.This case is now being downgraded.Based on mdr reportability decision tree and the pqc investigation result, this case is not mdr reportable.On 14-sep-2017, the fda confirmed that the correct manufacturer report # (mfr #) for this case should be 3000718406-2014-00002.This report and all further follow-ups for this case will be re-submitted under the corrected mfr #.

• Brand Name: BREATHTEK UBT KIT
• Type of Device: UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE
• Manufacturer (Section D): OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZ; 508 carnegie center drive; princeton NJ 08540
• Manufacturer (Section G): OTSUKA
• Manufacturer Contact: mirza rahman ; 508 carnegie center drive; princeton, NJ 08540
• MDR Report Key: 4162880
• MDR Text Key: 20015318
• Report Number: 3000718406-2014-00002
• Device Sequence Number: 1
• Product Code: MSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 54 YR