BREATHTEK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99,consumer,unknown report with the FDA on 2014-03-21 for BREATHTEK manufactured by Otsuka Pharmaceutical.

Event Text Entries

[4274734] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3000718406-2014-00001
• MDR Report Key: 3720491
• Report Source: 99,CONSUMER,UNKNOWN
• Date Received: 2014-03-21
• Date of Report: 2017-10-20
• Date of Event: 2013-12-01
• Date Mfgr Received: 2017-09-14
• Date Added to Maude: 2014-04-08
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: DR. MIRZA RAHMAN
• Manufacturer Street: 508 CARNEGIE CENTER DRIVE SUITE 500
• Manufacturer City: PRINCETON NJ 08540
• Manufacturer Country: US
• Manufacturer Postal: 08540
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BREATHTEK
• Generic Name: UREA BREATH TEST (UBT) AND CALCULATION SOFTWARE
• Product Code: MSQ
• Date Received: 2014-03-21
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OTSUKA PHARMACEUTICAL
• Manufacturer Address: 508 CARNEGIE CENTER PRINCETON NJ 08540 US 08540

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-03-21