MAUDE Adverse Event Report: MERIDIAN BIOSCIENCE INC. BREATHTEK UBT

Model Number 01

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

Patient Problem Vomiting (2144)

Event Date 01/05/2023

Event Type  Injury  

Event Description

Patient completed ubt testing on (b)(6) 2023 at 8:04am.Customer noted that when leaving the ubt testing, patient had a headache similar to a past migraine but had indicated that she had not had a migraine in over a year.Patient went home and was experiencing nausea, vomiting, diarrhea, and "talking out of her head".Patient began vomiting around noon (12:00pm).At 2:00pm, she was taken to the emergency room by her husband where she was diagnosed with a hypertensive emergency.It was noted that a hemorrhage was seen on her ct scan.Customer reported that the patient was discharged from the hospital in the afternoon on (b)(6) 2023.Customer reported that the discharge noted mentioned that there were no acute findings.While there is no indication that the performance of or results provided by the breathtek caused or contributed to the patient's condition, meridian bioscience has elected to submit an mdr out of an extreme abundance of caution.

• Brand Name: BREATHTEK UBT
• Type of Device: BREATHTEK UBT
• Manufacturer (Section D): MERIDIAN BIOSCIENCE INC.; 3471 river hills dr.; cincinnati OH 45244
• Manufacturer Contact: megan berling ; 3471 river hills dr.; cincinnati, OH 45244 ; 5139914142
• MDR Report Key: 16161261
• MDR Text Key: 307460756
• Report Number: 1524213-2023-00001
• Device Sequence Number: 1
• Product Code: OZA
• UDI-Device Identifier: 00840733101434
• UDI-Public: 00840733101434
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P100025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 01
• Device Catalogue Number: 8209
• Device Lot Number: 383K05S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 81 YR
• Patient Sex: Female