ARCHITECT FREE T4
Received Jul 22, 2025 · Event occurred Jul 4, 2025
Report 3005094123-2025-00366 · MDR key 22568211
Device
Generic name
Radioimmunoassay, Free Thyroxine
Manufacturer
Abbott Ireland Diagnostics DivisionCatalog number
07K65-29
Lot number
72001UD00
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (EXPECTED VALUE = 0.70 - 1.48 NG/DL): FREE T4 1.50 NG/DL, REPEATED 1.10 / 1.12 / 1.16 NG/DL. OTHER RESULTS PROVIDED: TSH: 1.5784 UIU/ML (EXPECTED VALUE = 0.35 - 4.94 IU/ML) FREE T3: 3.05 PG/ML (EXPECTED VALUE = 1.58-3.91 PG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, AND DEVICE HISTORY RECORD REVIEW. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. REVIEW OF TRACKING AND TRENDING DATA FOR THE ARCHITECT FREE T4 ASSAY DID IDENTIFY AN INCREASE IN COMPLAINTS. HOWEVER, AN INCREASE IN COMPLAINT ACTIVITY WAS NOT IDENTIFIED FOR THE REAGENT LOT. DEVICE HISTORY REVIEW DID NOT IDENTIFY ISSUES ASSOCIATED WITH THE CUSTOMER¿S OBSERVATION. ACCURACY TESTING WAS COMPLETED WITH A RETAINED KIT OF THE COMPLAINT LOT. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET DURING COMPLETION OF THE PROTOCOL, DEMONSTRATING THAT THE LOT IS PERFORMING AS EXPECTED. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT FREE T4 REAGENT WAS IDENTIFIED.
Description of Event or Problem
THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT FREE T4 RESULTS FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (EXPECTED VALUE = 0.70 - 1.48 NG/DL): FREE T4 1.50 NG/DL, REPEATED 1.10 / 1.12 / 1.16 NG/DL. OTHER RESULTS PROVIDED: TSH: 1.5784 UIU/ML (EXPECTED VALUE = 0.35 - 4.94 IU/ML) FREE T3 : 3.05 PG/ML (EXPECTED VALUE = 1.58-3.91 PG/ML). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Additional Manufacturer Narrative
AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.