ELECSYS FT3 III
Received Oct 23, 2023 · Event occurred Sep 22, 2023
Report 1823260-2023-03400 · MDR key 17990050
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
09005811190Catalog number
09005811190
Lot number
669112
Product problems
- High Test Results
- Low Test Results
- High Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE MEDICAL DEVICE PROBLEM CODE WAS UPDATED. THE INVESTIGATION OF THE PROVIDED SAMPLE DETECTED AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE ASSAY CAUSING THE FALSELY ELEVATED VALUE OF THE FT3III ASSAY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE WAS DUE TO THE DETECTED INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE ASSAY. 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.
Additional Manufacturer Narrative
THE SAMPLE WAS PROVIDED FOR INVESTIGATION ON (B)(6) 2023. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
**UDI RELATED DATA QUALITY UPDATES ONLY** D3 IS THE INITIAL DISTRIBUTOR IN THE US.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH THE ELECSYS FT3 III ASSAY ON A COBAS 8000 E801 MODULE. THE SAMPLE ALSO HAD DISCREPANT RESULTS WHEN TESTED ON ANOTHER COBAS 8000 E801 MODULE AND ON A COBAS E411 IMMUNOASSAY ANALYZER. REFER TO THE ATTACHMENT FOR THE PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED AND REPEATED ON THE CUSTOMER'S E801 ANALYZER. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED ON A 2ND E801 ANALYZER AND ON E411 ANALYZER ON (B)(6) 2023. THE SAMPLE WAS ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF E801 ANALYZER USED AT THE CUSTOMER'S SITE WAS (B)(6). THE SERIAL NUMBER OF E801 ANALYZER USED FOR INVESTIGATION WAS (B)(6). THE SERIAL NUMBER OF E411 ANALYZER USED FOR INVESTIGATION WAS (B)(6). THE FT3 III REAGENT EXPIRATION DATE USED AT THE CUSTOMER SITE WAS NOT PROVIDED. THE FT3 III REAGENT LOT NUMBER USED ON COBAS E801 WAS 669112 WITH AN EXPIRATION DATE OF 29-FEB-2024. THE FT3 III REAGENT LOT NUMBER USED ON COBAS E411 WAS 686656 WITH AN EXPIRATION DATE OF 30-APR-2024. THE INVESTIGATION IS ONGOING.