ELECSYS FT3 III
Received Aug 23, 2023 · Event occurred Jul 25, 2023
Report 1823260-2023-02748 · MDR key 17604103
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsCatalog number
09005811190
Lot number
668112
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
Patient
60 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. IT WAS DETERMINED THAT THE PATIENT SAMPLE CONTAINED AN INTERFERENCE AGAINST THE ANTIBODY/IDIOTYPE COMPONENT OF THE FT3 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." NO PRODUCT PROBLEM WAS IDENTIFIED.
Additional Manufacturer Narrative
THE FIRST E801 ANALYZER SERIAL NUMBER IS 1824-08. THE SERIAL NUMBER OF THE SECOND E801 ANALYZER WAS NOT PROVIDED. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS FT3 III RESULTS FOR 1 PATIENT SAMPLE ON TWO COBAS E 801 ANALYTICAL UNITS COMPARED TO AN ABBOTT ANALYZER. ON (B)(6) 2023, THE RESULT FROM THE FIRST E801 ANALYZER WAS 9.36 PMOL/L. ON (B)(6) 2023, THE SAMPLE WAS TESTED ON THE SECOND E801 ANALYZER AND THE RESULT WAS 9.18 PMOL/L. ON (B)(6) 2023, THE RESULT FROM THE ABBOTT ARCHITECT WAS 3.95 PMOL/L. THE REFERENCE RANGES WERE REQUESTED BUT NOT PROVIDED.