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

OTSUKA PHARMACEUTICAL BREATHTEK; UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE

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Lot Number 002215AG

Device Problem Nonstandard Device (1420)

Patient Problems Low Blood Pressure/ Hypotension (1914); Respiratory Distress (2045); Reaction (2414)

Event Date 06/13/2016

Event Type Injury

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

Very bad reaction from it and had to go to the er [adverse reaction], nose was plugged up [nose congestion], she had a lot of phlegm [phlegm], difficulty breathing [difficulty breathing], unable to speak [speech disorder].Case description: this report was received from (b)(4) on 14-jun-2016.The initial received 14jun2016 and fu1 received 15jun2016 were processed together.A reporter reported that a (b)(6) female patient while taking breathtek ubt kit (breathtek ubt kit) on 13-jun-2016 for an unknown dose by mouth for helicobacter pylori.On an unknown date, the patient's endoscopy showed that she had "bacteria." her doctor prescribed an antibiotic for her.The patient has been taking the antibiotic before pranactin-citric with 4-5 days left of it.On (b)(6) 2016, the patient took pranactin-citric.She had a very bad reaction from it and had to go to the er.Her nose was plugged up, she had a lot of phlegm, had difficulty breathing and she was unable to speak.At the er, she was treated with iv steroids and benadryl.Her concomitant medication are amlodipine (amlodipine) for product used for unknown indication, aspirin (acetylsalicylic acid) for product used for unknown indication and hydrochlorothiazide (hydrochlorothiazide) for product used for unknown indication.The patient experienced phlegm, off label use, speech disorder, nose congestion, adverse reaction and difficulty breathing on (b)(6) 2016.Diagnostic tests revealed the following results: unknown date: endoscopy, "bacteria", on (b)(6) 2016, "ekg," unknown results, on (b)(6) 2016: pulse, good, on (b)(6) 2016: other unknown tests, "everything else was okay".The following lab tests were received : on (b)(6) 2016 blood pressure measurement: "bp was a little high".As of (b)(6) 2016, the patient has stopped the pranactin-citric.The patient did not know the expiration date.Additional information was received on 15-jun-2016 (clarification received from pqc).Follow up call was placed to the patient by the complaint coordinator.She said that she had been taking an unspecified antibiotic for a "couple of weeks" before taking the breathtek test and ingesting the pranactin.She said that a "receptionist" at the clinic had given her the two bags and the instructions on how to take the breathtek test.However, she became ill after completing the test.She did not have the kit in her possession and was unable to confirm the reported lot number.She said that the clinic may still have the kit and/or lot number and she gave her permission to contact the clinic.The patient had not taken a breathtek test in the past.Her call to the call center was to ask what the ingredients were in the pranactin solution.Follow up call was placed to the patient by the complaint coordinator.A voice mail message was left on the nurses' line explaining the nature of the call and a call back was requested.Follow up requested.Otsuka causality assessment: the reported events "phlegm", "speech disorder", "nose congestion", "adverse reaction" and "difficulty breathing" were considered related to breathtek ubt kit, given the temporal association.However limited information precludes a meaningful medical assessment.The event device use error was considered as non ae.Additional information requested.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.Follow up information was received on 19-august-2016 via closed pqc record for id 50130: based on the product quality complaint investigation results, the root cause of the complaint is undetermined.There is no device malfunction.The complaint is not confirmed.Batch record review: a lot number was not provided for the subject complaint; therefore, a review of the batch record could not be performed 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: as the lot number was not provided for the subject complaint, an evaluation of the retain sample could not be conducted.No additional information was requested.Follow up information was received on 19-august-2016 via closed pqc record for id 51540: based on the product quality complaint investigation results, the root cause of the complaint is "determined" and based on investigation there is no device malfunction batch record review: as the lot number was not provided for the subject complaint, an evaluation of the retain sample could not be conducted.Desc/evaluation of comp sample the complaint sample was not available for return, therefore complaint sample was not evaluated.Retain sample evaluation as the lot number was not provided for the subject complaint, an evaluation of the retain sample could not be conducted.Since kit lot numbers were not provided for this complaint, the following potential kit lot numbers were provided: 209k05h, 210k05h, 211k05h, 212k05h, 213k05h, 214k05h, 215k05h, 216k05h, 217k05h, 218k05h, 219k05h, and 220k05h as potential kit numbers for this complaint based on sales and distribution data for the product.These kit lot numbers were used to cross reference with the breathtek genealogy spreadsheet and determine the potential cmic bulk lots which are as follows: kit lot number-----cmic bulk lot# 209k05h------cc5bp03a16, 210k05h------cc5bp03a17, 211k05h------cc5bp03a18, 212k05h------cd5bp03a13, 213k05h------cd5bp03a14, 214k05h------cd5bp03a15, 215k05h------cd5bp03a17, 216k05h------cd5bp03a18, 217k05h------cd5bp03a19, 218k05h------ce5bp03a04, 219k05h------ce5bp03a05, 220k05h------ce5bp03a06.The investigation was forwarded to cmic for further evaluation and investigation.Batch records were re-reviewed by cmic cmo and no manufacturing related deviations, anomalies or observations were noted for having any product impact to these batches.All batches manufactured at cmic cmo usa corporation are made and tested as per cgmp.All batch records were qa reviewed and approved by cmic and otsuka qa.There have been no process changes or changes deemed to impact processing.The annual product review for this product reporting for 2015 reports that all in-process test data were within specifications with no discernible trend.Desc/evaluation of comp sample the complaint sample was not available for return, therefore complaint sample was not evaluated.Retain sample evaluation as the lot number was not provided for the subject complaint, an evaluation of the retain sample could not be conducted.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.Otsuka causality assessment: the reported events "phlegm", "speech disorder", "nose congestion", "adverse reaction" and "difficulty breathing" were considered related to breathtek ubt kit, given the temporal association.However limited information precludes a meaningful medical assessment.The event device use error was considered as non ae.Based on the product quality complaint investigation results (51540 and 50130), the root cause of the complaint is "determined" and based on investigation there is no device malfunction 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.Follow up attempts ongoing.

Event Description

This report was received from (b)(6) (b)(4) on 14-jun-2016.The initial received 14-jun-2016 and follow-up 1 received 15-jun-2016 were processed together.A reporter reported that a (b)(6)-year-old female patient while taking breathtek ubt kit (breathtek ubt kit) on (b)(6) 2016 for an unknown dose by mouth for helicobacter pylori.On an unknown date, the patient's endoscopy showed that she had "bacteria." her doctor prescribed an antibiotic for her.The patient has been taking the antibiotic before pranactin-citric with 4-5 days left of it.On (b)(6) 2016, the patient took pranactin-citric.She had a very bad reaction from it and had to go to the er.Her nose was plugged up, she had a lot of phlegm, had difficulty breathing and she was unable to speak.At the er, she was treated with iv steroids and benadryl.Her concomitant medication are amlodipine (amlodipine) for product used for unknown indication, aspirin (acetylsalicylic acid) for product used for unknown indication and hydrochlorothiazide (hydrochlorothiazide) for product used for unknown indication.The patient experienced phlegm, off label use, speech disorder, nose congestion, adverse reaction and difficulty breathing on (b)(6) 2016.Diagnostic tests revealed the following results: unknown date: endoscopy, "bacteria".On (b)(6) 2016, "ekg," unknown results.On(b)(6) 2016: pulse, good.On (b)(6) 2016: other unknown tests, "everything else was okay".The following lab tests were received: on (b)(6) 2016 blood pressure measurement: "bp was a little high".As of (b)(6) 2016, the patient has stopped the pranactin-citric.The patient did not know the expiration date.Additional information was received on 15-jun-2016 (clarification received from pqc).Follow up call was placed to the patient by the complaint coordinator.She said that she had been taking an unspecified antibiotic for a "couple of weeks" before taking the breathtek test and ingesting the pranactin.She said that a "receptionist" at the clinic had given her the two bags and the instructions on how to take the breathtek test.However, she became ill after completing the test.She did not have the kit in her possession and was unable to confirm the reported lot number.She said that the clinic may still have the kit and/or lot number and she gave her permission to contact the clinic.The patient had not taken a breathtek test in the past.Her call to the call center was to ask what the ingredients were in the pranactin solution.Follow up call was placed to the patient by the complaint coordinator.A voice mail message was left on the nurses' line explaining the nature of the call and a call back was requested.Follow up requested.Otsuka causality assessment: the reported events "phlegm", "speech disorder", "nose congestion", "adverse reaction" and "difficulty breathing" were considered related to breathtek ubt kit, given the temporal association.However limited information precludes a meaningful medical assessment.The event device use error was considered as non ae.Additional information requested.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.Follow up information was received on 19-august-2016 via closed pqc record for id (b)(4): based on the product quality complaint investigation results, the root cause of the complaint is undetermined.There is no device malfunction.The complaint is not confirmed.Batch record review: a lot number was not provided for the subject complaint; therefore, a review of the batch record could not be performed.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: as the lot number was not provided for the subject complaint, an evaluation of the retain sample could not be conducted.No additional information was requested.Follow up information was received on 19-august-2016 via closed pqc record for id 51540: based on the product quality complaint investigation results, the root cause of the complaint is "undetermined" and based on investigation there is no device malfunction batch record review: as the lot number was not provided for the subject complaint, an evaluation of the retain sample could not be conducted.Desc/evaluation of comp sample: the complaint sample was not available for return, therefore complaint sample was not evaluated.Retain sample evaluation: as the lot number was not provided for the subject complaint, an evaluation of the retain sample could not be conducted.Since kit lot numbers were not provided for this complaint, the following potential kit lot numbers were provided: 209k05h, 210k05h, 211k05h, 212k05h, 213k05h, 214k05h, 215k05h, 216k05h, 217k05h, 218k05h, 219k05h, and 220k05h as potential kit numbers for this complaint based on sales and distribution data for the product.These kit lot numbers were used to cross reference with the breathtek genealogy spreadsheet and determine the potential cmic bulk lots which are as follows: kit lot number-----cmic bulk lot# 209k05h------cc5bp03a16, 210k05h------cc5bp03a17, 211k05h------cc5bp03a18, 212k05h------cd5bp03a13, 213k05h------cd5bp03a14, 214k05h------cd5bp03a15, 215k05h------cd5bp03a17, 216k05h------cd5bp03a18, 217k05h------cd5bp03a19, 218k05h------ce5bp03a04, 219k05h------ce5bp03a05, 220k05h------ce5bp03a06.The investigation was forwarded to cmic for further evaluation and investigation.Batch records were re-reviewed by cmic cmo and no manufacturing related deviations, anomalies or observations were noted for having any product impact to these batches.All batches manufactured at cmic cmo usa corporation are made and tested as per cgmp.All batch records were qa reviewed and approved by cmic and otsuka qa.There have been no process changes or changes deemed to impact processing.The annual product review for this product reporting for 2015 reports that all in-process test data were within specifications with no discernible trend desc/evaluation of comp sample: the complaint sample was not available for return, therefore complaint sample was not evaluated.Retain sample evaluation: as the lot number was not provided for the subject complaint, an evaluation of the retain sample could not be conducted.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.Otsuka causality assessment: the reported events "phlegm", "speech disorder", "nose congestion", "adverse reaction" and "difficulty breathing" were considered related to breathtek ubt kit, given the temporal association.However limited information precludes a meaningful medical assessment.The event device use error was considered as non ae.Based on the product quality complaint investigation results ((b)(4)), the root cause of the complaint is "undetermined" and based on investigation there is no device malfunction 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.Follow up attempts ongoing.On 14sep2017, the fda confirmed that the correct manufacturer report # (mfr #) for this case should be 3000718406-2016-00001.This report and all further follow-ups for this case will be re-submitted under the corrected mfr #.

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Brand Name

BREATHTEK

Type of Device

UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE

Manufacturer (Section D)

OTSUKA PHARMACEUTICAL

508 carnegie center drive

princeton, nj MD 08540

Manufacturer Contact

mirza rahman

508 carnegie center drive

princeton, NJ 08540

6095359429

MDR Report Key

5780392

MDR Text Key

49129874

Report Number

3000718406-2016-00001

Device Sequence Number

Product Code

MSQ

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

P100025

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

consumer,other

Reporter Occupation

Other

Type of Report

Initial,Followup,Followup

Report Date

11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

Date FDA Received

07/08/2016

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Device Operator

Lay User/Patient

Device Lot Number

002215AG

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

Date Manufacturer Received

09/14/2017

Was Device Evaluated by Manufacturer?

Device Not Returned to Manufacturer

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Required Intervention;

Patient Age

50 YR

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

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