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

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

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Case description: information received on (b)(6) 2014: a pregnant female consumer, age unknown, reported using pranactin citric, 1 dose, on an unknown date as preparation for the breath tek 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 patient's relevant past drug history and concomitant medications are unknown.

Manufacturer Narrative

Follow-up information received on (b)(6), 2014: spoke to the reporter and her mother.The patient was worried about the use of breath tek while pregnant.The patient declined consent to contact her physician.And she still has to think about it and discuss it with her obgyn.She wanted more information on the use of breathtek in pregnant women.Follow-up information received on (b)(6) 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 breath tek test for h.Pylori.Relevant medical history, concomitant medications,a nd 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 (b)(6) 2015: the pqc investigation closed record was received.The summary was as follows: follow-up information was received on (b)(6) 2014.Product quality investigation completed ((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 may 2013) for breath tek 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 breath tek ubt kit.Evaluation summary: follow-up information was received on (b)(6) 2014.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)(4) 2013) for breath tek 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.This case was forwarded 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 team as part of the monthly reconciliation process.

• Brand Name: BREATH TEK UBT KIT
• Type of Device: UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE
• Manufacturer (Section D): OTSUKA AMERICA PHARMACEUTICAL INC.; rockville MD
• Manufacturer (Section G): OTSUKA AMERICA PHARMACEUTICAL INC.; 2440 research blvd.; rockville MD 20850
• Manufacturer Contact: mirza rahman ; 508 carnegie center; princeton, NJ 08540 ; 6095359429
• MDR Report Key: 4736135
• MDR Text Key: 21469231
• Report Number: 3000718406-2015-00004
• 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
• Type of Report: Initial
• Report Date: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2015
• 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