ELECSYS FT3 III
Received Aug 11, 2023 · Event occurred Jul 19, 2023
Report 1823260-2023-02604 · MDR key 17515297
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsCatalog number
09005803190
Lot number
686656
Product problems
- High Test Results
- High Test Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. ASSAYS FROM DIFFERENT VENDORS CAN GENERATE DIFFERENT VALUES. THIS RELATES TO THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS/METHODS, AND DIFFERENCES IN THE STANDARDIZATION METHODOLOGY USED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH THE ELECSYS TSH, ELECSYS FT3 III, AND THE ELECSYS FT4 IV ASSAY ON A COBAS 6000 E601 MODULE. THE QUESTIONABLE RESULTS DO NOT CORRESPOND TO THE PATIENT¿S CLINICAL PICTURE. THE FIRST SAMPLE WAS ALSO TESTED ON A COBAS E 801 ANALYZER. THE SECOND SAMPLE WAS ALSO TESTED USING THE ABBOTT ARCHITECT TSH, FT3 AND FT4 METHODS. THIS MEDWATCH WILL APPLY TO THE FT3 III ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY AND TO THE MEDWATCH WTH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT4 IV ASSAY. REFER TO THE ATTACHMENT FOR ALL RELEVANT TEST DATA. THE SERIAL NUMBER OF THE CUSTOMER'S E 601 ANALYZER WAS (B)(6). THE SERIAL NUMBER OF THE CUSTOMER¿S E 801 WAS REQUESTED BUT NOT PROVIDED.