ELECSYS FT3 III
Received Nov 14, 2023 · Event occurred Oct 17, 2023
Report 1823260-2023-03593 · MDR key 18130672
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
09005811190Catalog number
09005811190
Lot number
ASKU, 669112, 686656
Product problems
- High Test Results
- High Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE CUSTOMER'S E 801 MODULE IS UNKNOWN. THE SERIAL NUMBER OF THE INVESTIGATION SITE'S E 801 MODULE IS (B)(6). THE SERIAL NUMBER OF THE INVESTIGATION SITE'S E 411 MODULE IS (B)(6). THE FT3 III REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 801 IS 669112 WITH AN EXPIRATION DATE OF 29-FEB-2024. THE FT3 III REAGENT LOT NUMBER USED AT THE INVESTIGATION SITE'S E 411 IS 686656 WITH AN EXPIRATION DATE OF 30-APR-2024. THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS FT3 III AND ELECSYS FT4 IV RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE CUSTOMER'S COBAS E 801 MODULE, AND THE INVESTIGATION SITE'S COBAS E 801 AND COBAS E 411 MODULES. THIS MDR IS FOR THE FT3 III ASSAY. PLEASE REFER TO MEDWATCH WITH A1 - PATIENT IDENTIFIER (B)(6) FOR THE FT4 IV ASSAY. THE DATE THE INFORMATION WAS RECEIVED WAS USED AS THE DATE OF THE EVENT. THE PATIENT SAMPLE WAS SENT TO THE INVESTIGATION SITE THAT USES A COBAS E 801 AND AN E 411 AND AN OUTSOURCED LABORATORY THAT USES AN ABBOTT ARCHITECT; DISCREPANT RESULTS WERE NOTED. PLEASE REFER TO THE ATTACHMENT IN THE MEDWATCH "(B)(6)" FOR THE HIGHLIGHTED QUESTIONABLE RESULTS.
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE INVESTIGATION WAS ABLE TO REPRODUCE THE CUSTOMER'S FT3 AND FT4 RESULTS. THE INVESTIGATION TESTED THE PATIENT SAMPLE FOR THE PRESENCE OF AN INTERFERENT. THE INVESTIGATION CONFIRMED THE PRESENCE OF AN INTERFERENT AGAINST THE FT3 ANTIBODY/IDIOTYPE. 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.
Additional Manufacturer Narrative
**UDI RELATED DATA QUALITY UPDATES ONLY** D3 IS THE INITIAL DISTRIBUTOR IN THE US.