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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hyperglycemia (1905)

Event Date 12/01/2013

Event Type  Injury  

Event Description

Blood sugars high [blood sugar increased].Case description: info received on (b)(6) 2014: a pregnant female consumer, age unk, reported using pranactin citric, 1 dose, on an unk date as preparation for the breathtek test for an unk indication.This consumer reported taking pranactin citric once on an unk date while 23 weeks pregnant.She reported on an unk date after taking pranactin citric she did an hour long test and a 4 hour test for blood sugars and both were high.It was unk if the blood sugar readings post pranactin citric are higher than those prior to the test.As of (b)(6) 2014, she has completed her use of pranactin citric and her blood sugars continued to be high; she has not seen her physician yet, but was not aware of any problems with the baby.Lot and expiration date were not provided.Relevant medical history included being borderline for gestational diabetes.The pt's relevant past drug history and concomitant medications are unk.Follow-up info received on (b)(6) 2014: spoke to the reporter and her mother.The pt was worried about the use of breathtek while pregnant.The pt declined consent to contact her physician.And she still has to think about it and discuss it with her ob/gyn.She wanted more info on the use of breathtek in pregnant women.Follow-up info received on (b)(6) 2014: this lab supervisor reported on a pregnant woman in her 20's who took pranactin citric, 1 dose, in (b)(6) 2013 as preparation for the breathtek test for h pylori.Relevant medical history, concomitant medications, and drug history are unk.The pt knew she was pregnant in (b)(6) 2013 at the time the pranactin citric was taken, resulting in an exposure in utero.Lab data was unk.As of (b)(6) 2014, the pt has completed use of pranactin citric and the outcome of the exposure in utero was unk.Lot and expiration date are unk.

Event Description

Information received on 25-feb-2014: a pregnant female consumer, age unknown, reported using pranactin citric, 1 dose, on an unknown date as preparation for the breathtek test for an unknown indication.This consumer reported taking pranactin citric once on an unknown date while 23 weeks pregnant.She reported on an unknown date after taking pranactin citric she did an hour long test and a 4 hour test for blood sugars and both were high.It was unknown if the blood sugar readings post pranactin citric are higher than those prior to the test.As of (b)(6) 2014 she has completed her use of pranactin citric and her blood sugars continued to be high; she has not seen her physician yet, but was not aware of any problems with the baby.Lot and expiration date were not provided.Relevant medical history included being borderline for gestational diabetes.The patients' relevant past drug history and concomitant medications are unknown.Follow- up information received on 26-feb-2014: spoke to the reporter and her mother.The patient was worried about the use of breathtek while pregnant.The patient declined consent to contact her physician.And she still has to think about it and discuss it with her ob/gyn.She wanted more information on the use of breathtek in pregnant women.Follow-up information received on 26-feb-2014: this laboratory supervisor reported on a pregnant woman in her 20's who took pranactin citric, 1 dose, in (b)(6) 2013 as preparation for the breathtek test for h.Pylori.Relevant medical history, concomitant medications, and drug history are unknown.The patient knew she was pregnant in (b)(6) 2013 at the time the pranactin citric was taken, resulting in an exposure in utero.Lab data was unknown.As of (b)(6) 2014 the patient has completed use of pranactin citric and the outcome of the exposure in utero was unknown.Lot and expiration date are unknown.Follow up received 12mar2015: the pqc investigation closed record was received.The summary was as follows.Follow-up information was received on 26-feb-2014.Product quality investigation completed ( track wise # (b)(4)) the patient knew she was pregnant in (b)(6) 2013 at the time the pranactin citric was taken, resulting in an exposure in utero.Lab data was unknown.As of (b)(6) 2014 the patient has completed use of pranactin citric and the outcome of the exposure in utero was unknown.Lot and expiration date are unknown.The prescribing information (revision: (b)(6) 2013) for breathtek¿ ubt for h.Pylori kit was reviewed by the qm complaint unit.Section 4 (warning and precautions) states the following: "pregnancy: no information is available on use of the pranactin-citric solution during pregnancy".Therefore, the root cause of the reported issue is documentation failure (no information available) regarding the prescribing information.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.This report from pqc perspective does not meet the requirement for mdr reportability.This report and all subsequent follow-ups will be submitted under mfg report number 9107159-2015-00004.Otsuka's causality statement: the event of blood glucose increased is unrelated to breathtek ubt kit.This report and all further follow-ups for this case will be re-submitted under the corrected mfr #.

Event Description

Information received on 25-feb-2014: a pregnant female consumer, age unknown, reported using pranactin citric, 1 dose, on an unknown date as preparation for the breathtek test for an unknown indication.This consumer reported taking pranactin citric once on an unknown date while 23 weeks pregnant.She reported on an unknown date after taking pranactin citric she did an hour long test and a 4 hour test for blood sugars and both were high.It was unknown if the blood sugar readings post pranactin citric are higher than those prior to the test.As of 25-feb-2014 she has completed her use of pranactin citric and her blood sugars continued to be high; she has not seen her physician yet, but was not aware of any problems with the baby.Lot and expiration date were not provided.Relevant medical history included being borderline for gestational diabetes.The patients' relevant past drug history and concomitant medications are unknown.Follow- up information received on 26-feb-2014: spoke to the reporter and her mother.The patient was worried about the use of breathtek while pregnant.The patient declined consent to contact her physician.And she still has to think about it and discuss it with her ob/gyn.She wanted more information on the use of breathtek in pregnant women.Follow-up information received on 26-feb-2014: this laboratory supervisor reported on a pregnant woman in her 20's who took pranactin citric, 1 dose, in (b)(6) 2013 as preparation for the breathtek test for h.Pylori.Relevant medical history, concomitant medications, and drug history are unknown.The patient knew she was pregnant in (b)(6) 2013 at the time the pranactin citric was taken, resulting in an exposure in utero.Lab data was unknown.As of (b)(6) 2014 the patient has completed use of pranactin citric and the outcome of the exposure in utero was unknown.Lot and expiration date are unknown.Follow up received 12mar2015: the pqc investigation closed record was received.The summary was as follows.Follow-up information was received on 26-feb-2014.Product quality investigation completed ( track wise # (b)(4)).The patient knew she was pregnant in (b)(6) 2013 at the time the pranactin citric was taken, resulting in an exposure in utero.Lab data was unknown.As of (b)(6) 2014 the patient has completed use of pranactin citric and the outcome of the exposure in utero was unknown.Lot and expiration date are unknown.The prescribing information (revision: (b)(6) 2013) for breathtek¿ ubt for h.Pylori kit was reviewed by the qm complaint unit.Section 4 (warning and precautions) states the following: "pregnancy: no information is available on use of the pranactin-citric solution during pregnancy".Therefore, the root cause of the reported issue is documentation failure (no information available) regarding the prescribing information.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.This report from pqc perspective does not meet the requirement for mdr reportability.This report was previously submitted under mfg report number 3000718406-2014-00001.This report and all subsequent follow-ups will be submitted under mfg report number 9107159-2015-00004.Otsuka's causality statement: the event of blood glucose increased is unrelated to breathtek ubt kit.On 14sep2017, the fda confirmed that the correct manufacturer report # (mfr #) for this case should be 3000718406-2014-00001.This report and all further follow-ups for this case will be re-submitted under the corrected mfr #.

• Brand Name: BREATHTEK
• Type of Device: UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE
• Manufacturer (Section D): OTSUKA PHARMACEUTICAL; 508 carnegie center; princeton NJ 08540
• Manufacturer Contact: mirza rahman ; 508 carnegie center drive; suite 500; princeton, NJ 08540
• MDR Report Key: 3720491
• MDR Text Key: 4274734
• Report Number: 3000718406-2014-00001
• 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: Unknown,consumer,unknown
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other