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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Burning Sensation (2146); Discomfort (2330)

Event Date 01/28/2011

Event Type  Injury  

Event Description

On 08-mar-2011, a male consumer reported that after taking pranactin-citric solution of an unknown amount he experienced burning feet and hand syndrome.The patient did not indicate whether he had sought medical assistance.Follow up received: in a follow up email on 22-mar-2011, the patient continued to experience burning pain and discomfort.Follow-up received: on 25-mar-2011, the consumer reported that he took the breathtek test around (b)(6) 2011.He retook the test around (b)(6) 2011.Two weeks later, around (b)(6) 2011, the consumer experienced a burning sensation on his palms and soles that progressed to achy leg muscles which made it painful to sit.He stated that his legs worsened throughout the course of the day and felt better when laying down.He noted that his hands and arms were sensitive to heat.He stated that his discomfort level was at an 8 out of 10 at the beginning but was at a 4 out of 10 at the time of reporting.The consumer visited his primary healthcare professional and an endocrinologist.The results of a blood test were normal with no elevated liver tests or vitamin deficiencies.Corrective treatment included gabapentin 300 mg.Follow-up received: the consumer stated that there had been no improvement in symptoms.The consumer was still experiencing leg pain.Despite having several tests done, the consumer's physician has been unable to diagnose what is the cause of the pain.Follow-up received: the consumer stated that at the time of this follow up there was no diagnosis.The consumer confirmed that an echocardiogram, electromyogram, magnetic resonance imaging scan, and an ultrasound of the legs were done and the results were normal.The consumer is still experiencing severe pain in both legs when standing or sitting.The consumer stated that the pain diminishes if he lays down and raises his legs above the heart.The consume is taking tramadol 50 mg for the pain.He states that without the pain medicine the blood pressure in his leg reaches 170/90 mmhg, increasing with the level of pain.Laboratory results show a low red blood cell count and high cholesterol.Follow-up information received on 07-jul-2015 from fda: (b)(6).Per the additional information received on 07-jul-2015, the patient has not recovered from the burning hand and feet syndrome.The clinical outcome for the achy leg muscles and painful to sit was unknown.Reviewed new information from fda letter dated june 11, 2015: the event outcome is recorded as disability or permanent damage, and the event has not resolved.The case was upgraded to serious due to these reasons.No other new medical information received.The case has limited information and further information is needed regarding patient's medical records, concomitant medications, investigation reports in order to perform a complete medical assessment.In reviewing the previous communications physician contact information was not provided which will be requested again.In view of the limited information and lack of alternative explanation the company assessment is events are related to breathtek.Closed pqc investigation report was received on 12-may-2017: all the batch records for the potential pranactin bulk lot numbers were re-reviewed and no deviations or anomalies were noted for all the batches.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 complaint investigation results, the root cause of the complaint is "undetermined" and based on investigation there is no device malfunction.Otsuka causality assessment: the case has limited information and further information is needed regarding patient's medical records, concomitant medications, investigation reports in order to perform a complete medical assessment.Although limited information is available, the reported events were considered as related to breathtek, given the temporal association, and lack of alternative explanation for the reported events.Based on the pqc results, the root cause of the complaint was "undetermined" and there was no device malfunction.

• Brand Name: BREATHTEK UBT KIT
• Type of Device: UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE
• Manufacturer (Section D): OTSUKA PHARMACEUTICALS; 508 carnegie center dr; princeton NJ 08540
• Manufacturer Contact: mirza rahman ; 508 carnegie center dr; princeton, NJ 08540
• MDR Report Key: 6607558
• MDR Text Key: 76509014
• Report Number: 3000718406-2017-00002
• 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
• Type of Report: Initial
• Report Date: 05/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GABAPENTIN; TRAMADOL
• Patient Outcome(s): Disability
• Patient Age: 57 YR
• Patient Weight: 82