ELECSYS FT3 III
Received Mar 8, 2024 · Event occurred Feb 9, 2024
Report 1823260-2024-00717 · MDR key 18870596
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005811190
Lot number
ASKU
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION OF BOTH SAMPLES DETECTED ASSAY-INTERFERING FACTORS CAUSING THE FALSELY ELEVATED VALUES OF THE FT3 III ASSAY. 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. THE ROOT CAUSE WAS DUE TO INTERFERING FACTORS DETECTED IN THE SAMPLES.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY ON A COBAS 8000 E801 MODULE. THE SAMPLES ALSO HAD DISCREPANT RESULTS WHEN TESTED ON ANOTHER COBAS 8000 E801 MODULE AND A COBAS E411 IMMUNOASSAY ANALYZER. REFER TO THE ATTACHMENT FOR THE PATIENTS' DATA. SAMPLE 1 WAS INITIALLY TESTED ON THE CUSTOMER'S E801 MODULE ON (B)(6) 2024 AND SAMPLE 2 WAS INITIALLY TESTED ON THE CUSTOMER'S E801 MODULE ON (B)(6) 2024. THE SAMPLES WERE PROVIDED FOR INVESTIGATION WHERE THEY TESTED ON AN E411 ANALYZER ON (B)(6) 2024 AND A 2ND E801 MODULE ON (B)(6) 2024. THE SAMPLES WERE ALSO REPEATED ON AN ABBOTT ARCHITECT ANALYZER ON (B)(6) 2024.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S E801 ANALYZER WAS REQUESTED BUT NOT PROVIDED. THE SERIAL NUMBER OF E411 ANALYZER USED FOR INVESTIGATION IS (B)(6) . THE SERIAL NUMBER OF E801 ANALYZER USED FOR INVESTIGATION IS (B)(6) . THE FT3 III V2 REAGENT EXPIRATION DATE USED AT THE CUSTOMER'S SITE WAS NOT PROVIDED. THE FT3 III V2 REAGENT LOT NUMBER USED ON COBAS E411 WAS 686656 WITH AN EXPIRATION DATE OF 30-APR-2024. THE FT3 III V2 REAGENT LOT NUMBER USED ON COBAS E801 WAS 669112 WITH AN EXPIRATION DATE OF 29-FEB-2024. THE 2 SAMPLES WERE PROVIDED FOR INVESTIGATION ON 06-MAR-2024. THE INVESTIGATION IS ONGOING.