ELECSYS FT3 III
Received Jul 18, 2023 · Event occurred Jun 20, 2023
Report 1823260-2023-02323 · MDR key 17340996
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
09005811190
Lot number
ASKU, 669112, 686656
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS FT3 III VER. 2 (FT3 V2) ASSAY ON MULTIPLE ROCHE ANALYZERS. THE SAMPLE WAS INITIALLY TESTED WITH FT3 V2 ON THE CUSTOMER'S COBAS E 801 ANALYTICAL UNIT ON AN UNKNOWN DATE. THE SAMPLE WAS PROVIDED FOR INVESTIGATION, WHERE IT WAS TESTED WITH THE FT3 V2 ASSAY ON A SECOND E801 ANALYZER ON (B)(6) 2023. DURING INVESTIGATIONS, THE SAMPLE WAS ALSO TESTED WITH THE FT3 V2 ASSAY ON A COBAS E 411 ANALYZER ON (B)(6) 2023. THE SAMPLE WAS ALSO REPEATED USING THE ABBOTT ARCHITECT FT3 METHOD ON (B)(6) 2023. REFER TO THE ATTACHMENT FOR ALL RELEVANT TEST DATA. THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER WAS NOT PROVIDED. THE SERIAL NUMBER OF THE E 801 ANALYZER USED FOR INVESTIGATION IS (B)(6). FT3 V2 REAGENT LOT NUMBER 669112, WITH AN EXPIRATION DATE OF 28-FEB-2024 WAS USED ON THIS ANALYZER. THE SERIAL NUMBER OF THE E411 ANALYZER USED FOR INVESTIGATION IS (B)(6). FT3 V2 REAGENT LOT 686656, WITH AN EXPIRATION DATE OF 28-APR-2024 WAS USED ON THIS ANALYZER.
Additional Manufacturer Narrative
THE SAMPLE WAS REQUESTED FOR INVESTIGATION.
Additional Manufacturer Narrative
THE SAMPLE WAS RECEIVED FOR INVESTIGATION. THE CUSTOMER'S FT3 III RESULTS WERE REPRODUCED. FURTHER INVESTIGATION OF THE SAMPLE CONFIRMED AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE REAGENT. THIS INTERFERENCE CAUSED THE HIGH FT3 III RESULTS. THE DIFFERENCE IN FT3 RESULTS WAS CAUSED BY THE DIFFERENT PHYSICAL REACTION CONDITIONS OF EACH ASSAY AND THE EFFECT ON THE IDENTIFIED INTERFERING FACTOR. PRODUCT LABELING STATES: "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. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.