BREATHTEK UBT
Received Feb 25, 2022 · Event occurred Jan 27, 2022
Report 1524213-2022-00002 · MDR key 13607465
Device
Product problems
- Improper or Incorrect Procedure or Method
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MERIDIAN BIOSCIENCE INC. HAS DETERMINED THAT AN MDR IS NEEDED AS THE CUSTOMER INGESTED THE PRANACTIN CTRIC SOLUTION WITHOUT WAITING THE REQUIRED 24 HOURS AS DICTATED BY PRODUCT LABELING. ALTHOUGH THERE WERE NO REPORTED ADVERSE EXPERIENCES, MERIDIAN IS SUBMITTING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION.
Description of Event or Problem
THE CUSTOMER HAD EXECUTED THE BREATHTEK UBT TEST AS PART OF AN INSTRUMENT TROUBLESHOOTING ACTIVITY. THE CUSTOMER STATED THAT THEY FOLLOWED THE PACKAGE INSERT INSTRUCTIONS FOR PERFORMING THE TEST. THIS INCLUDES ALL THAT IS REQUIRED PRIOR TO INGESTING THE SOLUTION, INGESTION, AND THEN BREATHING INTO THE BAGS. THE SAME PERSON REPEATED TESTING FOUR (4) HOURS LATER. THE CUSTOMER FAILED TO ADHERE TO THE INSTRUCTIONS INDICATING IF REPEAT TESTING IS NEEDED, THE BREATHTEK UBT CAN BE ADMINISTERED AGAIN THE FOLLOWING DAY.