ARCHITECT TOTAL T3 REAGENT KIT
Received Aug 28, 2023 · Event occurred Aug 15, 2023
Report 3005094123-2023-00228 · MDR key 17630252
Device
Generic name
Radioimmunoassay, Total Triiodothyronine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K64-74
Product problems
- Leak/Splash
- Leak/Splash
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE USER SPLASHED THE ARCHITECT TOTAL T3 CALIBRATOR INTO THEIR EYE. NO TREATMENT WAS PROVIDED. THE CUSTOMER WAS NOT WEARING EYE GOGGLES AT THE THE TIME OF THE INCIDENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
THE CUSTOMER REPORTED A SPLASH TO THE USER¿S EYE WITH THE ARCHITECT TOTAL T3 CALIBRATOR. THE CUSTOMER WAS NOT USING EYE PROTECTION LIKE SAFETY GLASSES. THE INVESTIGATION INCLUDED REVIEW OF PRODUCT HISTORICAL DATA, AND PRODUCT LABELING. REVIEW OF PRODUCT HISTORICAL DATA FOR ANY TRENDS AND ALL CUSTOMER COMPLAINTS RECEIVED FOR THIS ISSUE DID NOT IDENTIFY ANY TRENDS OR ABNORMAL COMPLAINT ACTIVITY. THE ARCHITECT TOTAL T3 ASSAY AND CALIBRATOR IS PERFORMING AS EXPECTED AND NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED. USE ERROR CONTRIBUTED TO THE COMPLAINT ISSUE.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.
Description of Event or Problem
THE USER SPLASHED THE ARCHITECT TOTAL T3 CALIBRATOR INTO THEIR EYE. NO TREATMENT WAS PROVIDED. THE CUSTOMER WAS NOT WEARING EYE GOGGLES AT THE THE TIME OF THE INCIDENT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.