ELECSYS T4
Received Jun 15, 2023 · Event occurred May 3, 2023
Report 1823260-2023-01975 · MDR key 17136179
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
T4Catalog number
09007784190
Lot number
62733100
Product problems
- High Test Results
- High Test Results
Patient
2 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BECKMAN ANALYZER RESULTS WERE PRODUCED ON (B)(6) 2023. THE RESULTS FROM (B)(6) 2023 WERE OBTAINED FROM THE SAME SAMPLE. THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. A GENERAL PRODUCT PROBLEM COULD BE EXCLUDED. THE INVESTIGATION FOUND THAT THE PATIENT SAMPLE CONTAINS AN INTERFERING FACTOR TO THE STREPTAVIDIN COMPONENT OF THE REAGENT. PER PRODUCT LABELING, "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN."
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). AN INTERFERING SUBSTANCE IS SUSPECTED IN THE PATIENT SAMPLE. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO A BECKMAN ANALYZER. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. CLARIFICATION ON IF THE RESULTS FROM (B)(6) 2023 WERE FROM A NEW SAMPLE WAS REQUESTED BUT NOT PROVIDED. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.