MAUDE Adverse Event Report: MERIDIAN BIOSCIENCE INC. BREATHTEK UBT

Model Number	01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 1524213-2023-00001
• Device Sequence Number: 12653162
• Product Code: OZA
• UDI-Device Identifier: 00840733101434
• UDI-Public: 00840733101434
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P100025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 81 YR
• Patient Sex: Female