MAUDE Adverse Event Report: OTSUKA AMERICA PHARMACEUTICALS, INC. BREATHTEK UBT KIT; UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Type  Injury  

Event Description

This spontaneous report was received from (b)(6) (b)(4) on (b)(6) 2016.Additional information received on 07-sep-2016 was combined with the initial.A consumer reported that on an unknown date in "2004 or 2006," after the female patient started the breathtek ubt kit (breathtek ubt kit), (unknown dose by mouth, one time dose), for helicobacter pylori urea breath test, she immediately experienced a "severe allergic reaction,"which required her to go to the emergency room.While she was in the emergency room she was given an "adrenaline shot;" after a few hours this "severe allergic reaction" resolved.This spontaneous report was received from (b)(6) (b)(4) on (b)(6) 2016.Additional information received on 07-sep-2016 was combined with the initial.The patient's medical history included irritable bowel syndrome, gluten sensitivity, allergy to cow's milk, allergy to grains, allergy to peanuts and tree nuts, allergy to whey protein allergy, and other products.She was on "other unknown concomitant medications." diagnostic tests revealed the following results: unspecified test administered to determine lactose intolerance.She did not finish the breathtek test as she had the allergic reaction prior to the final sample collection.The consumer could not say for certain if the test had definitely caused her allergic reaction.Her physician wants to administer a breathtek ubt kit in the near future.The outcome of severe allergic reaction was recovered/resolved.The consumer could not say for certain the previous testing had definitively caused her allergic reaction.Otsuka causality assessment: the reported event allergic reaction is considered as related to breathtek ubt kit, given the temporal association and positive dechallenge, however the patient also had significant history of gluten sensitivity, allergy to cow's milk, allergy to grains, allergy to peanuts and tree nuts, allergy to whey protein allergy, and other products, which could have also contributed to the reported event.The information provided by the reporter is also not clear, as it was reported the event happened in 2004 or 2006 and the consumer could not say for certain if the previous testing caused allergic reaction, which precludes a meaningful medical assessment.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.

Event Description

Severe allergic reaction [hypersensitivity].Case narrative: this spontaneous report was received from (b)(6) on (b)(6) 2016.Additional information received on 07-sep-2016, and on 03-feb-2017 was combined with the initial.A consumer reported that on an unknown date in ¿2004 or 2006,¿ after the female patient started the breathtek ubt kit (breathtek ubt kit), (unknown dose by mouth, one time dose), for helicobacter pylori urea breath test, she immediately experienced a ¿severe allergic reaction,¿ which required her to go to the emergency room.While she was in the emergency room she was given an ¿adrenaline shot;¿ after a few hours this ¿severe allergic reaction¿ resolved.The patient's medical history included irritable bowel syndrome, gluten sensitivity, allergy to cow's milk, allergy to grains, allergy to peanuts and tree nuts, allergy to whey protein allergy, and other products.She was on "other unknown concomitant medications".Diagnostic tests revealed the following results: unspecified test administered to determine lactose intolerance.She did not finish the breathtek test as she had the allergic reaction prior to the final sample collection.The consumer could not say for certain if the test had definitely caused her allergic reaction.Her physician wants to administer a breathtek ubt kit in the near future.The outcome of severe allergic reaction was recovered/resolved.The consumer could not say for certain the previous testing had definitively caused her allergic reaction.Otsuka causality assessment: the reported event allergic reaction is considered as related to breathtek ubt kit, given the temporal association and positive dechallenge, however the patient also had significant history of gluten sensitivity, allergy to cow's milk, allergy to grains, allergy to peanuts and tree nuts, allergy to whey protein allergy, and other products, which could have also contributed to the reported event.The information provided by the reporter is also not clear, as it was reported the event happened in 2004 or 2006 and the consumer could not say for certain if the previous testing caused allergic reaction, which precludes a meaningful medical assessment.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 received on 03-feb-2017.The pqc closed report was received on 03-feb-2017: 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: a lot number was not provided for the subject complaint; therefore retain testing is not required.However, oapi acquired breathtek as of september 2007.Batches manufactured from 2004 to 2006 were released for distribution by meretek.The stability studies which were on-going at the time of the acquisition were continued to completion by oapi.The stability data demonstrated that product met specifications through expiration date (various dates).Refer to attachment for tw 53014 stability summary.Pdf for additional details.Additionally, opdc-qm 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.There is no device malfunction.The complaint is not confirmed.Therefore, based on the current stability data and annual product review, the disposition for this complaint is not manufactured related.Otsuka causality assessment: the reported event allergic reaction was considered as related to breathtek ubt kit, given the temporal association and positive dechallenge, however the patient also had significant history of gluten sensitivity, allergy to cow's milk, allergy to grains, allergy to peanuts and tree nuts, allergy to whey protein allergy, and other products, which could be considered as an important risk factor for the reported event.The information provided by the reporter was also not clear, as it was reported the event happened in 2004 or 2006 and the consumer could not say for certain if the previous testing caused allergic reaction, which precludes a meaningful medical assessment.Based on the pqc report, the root cause of the complaint was undetermined, and there was 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.On 14sep2017, the fda confirmed that the correct manufacturer report # (mfr #) for this case should be 3000718406-2016-00002.This report and all further follow-ups for this case will be re-submitted under the corrected mfr #.Comment: not provided.

• Brand Name: BREATHTEK UBT KIT
• Type of Device: UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE
• Manufacturer (Section D): OTSUKA AMERICA PHARMACEUTICALS, INC.; 2440 research blvd; rockville MD 20850
• Manufacturer (Section G): OTSUKA; 2440 research blvd; rockville MD 20850
• Manufacturer Contact: mirza rahman ; 1 university square drive, suite 500; princeton, NJ 08540 ; 6095359429
• MDR Report Key: 5988891
• MDR Text Key: 55995954
• Report Number: 3000718406-2016-00002
• Device Sequence Number: 1
• Product Code: MSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2016
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention