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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Miscarriage (1962)

Event Type  Other  

Event Description

Miscarriage [miscarriage].Case description: on (b)(6) 2014, this consumer reported a possible drug exposure during pregnancy.This currently pregnant female consumer of unknown age started pranactin-citric, 1 dose, one, 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 unknown if there was any relevant laboratory data.As of (b)(6) 2014, she was not currently scheduled to take another breath tek test.The outcome of possible drug exposure was unknown.Lot and expiration date unknown.Follow-up received from physician on (b)(6) 2014: this (b)(6) year old female patient (date of birth: (b)(6) 1978) took prenactin-citric for the breath tek test on (b)(6) 2014 and about two 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) 20154 the mother was not on pranactin-citric and there were no concerns about the pregnancy at this time.

Manufacturer Narrative

Product quality complaint follow up received: 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 breath tek.It was unknown if there was any relevant laboratory data.It was reported in this cases that as of (b)(6) 2014, she was not currently scheduled to take another breath tek 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) year-old female patient (date of birth: (b)(6) 1978, 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 info available) regarding the prescribing info.The complaint is confirmed.This case was forwarded at the time it was received to cs&pv for safety review and assigned argus number (b)(4).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 ream as part of the monthly reconciliation process.The product quality complaint was closed.Follow-up received (b)(6) 2015: a follow-up call was made to the pt.The pt stated that she experienced miscarriage after taking breathtek test.The pt declined to provide further details about the incident and refused further contact.(b)(4) causality statement: this case has limited info.From the chronology provided the pt had a single exposure to the drug (breath tek) while pregnant on (b)(6) 2014.Approx three weeks later the history notes that there were no concerns about the pregnancy, and an ultrasound was done at an unk date which was appropriate 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.(b)(4) causality assessment: the event is related to the drug because of implied causality due to spontaneous reporting.Eval summary: the root cause of the reported issue is "documentation failure" (no info available) regarding the prescribing info.The complaint is confirmed.Based on the product quality complaint investigation results, the root cause of the complaint is "documentation failure" and there is no reported device malfunction.

• Brand Name: BREATH TEK UBT KIT
• Type of Device: UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE
• Manufacturer (Section D): OTSUKA AMERICA PHARMACEUTICALS INC.; rockville MD
• Manufacturer (Section G): OTSUKA AMERICA PHARMACEUTICALS INC.; 2440 research blvd.; rockville MD 20850
• Manufacturer Contact: mirza ; 508 carnegie ctr.; princeton, NJ 08540 ; 6095359429
• MDR Report Key: 4730617
• MDR Text Key: 5750228
• Report Number: 3000718406-2015-00005
• Device Sequence Number: 1
• Product Code: MSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR