ELECSYS T4
Received Mar 31, 2023 · Event occurred Mar 3, 2023
Report 1823260-2023-01050 · MDR key 16658616
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
07027885190
Lot number
65318702
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
TWO PATIENT SAMPLES WERE PROVIDED FOR INVESTIGATION. AN INTERFERING SUBSTANCE TO THE RUTHENIUM COMPONENT OF THE REAGENT WAS DETECTED. PER PRODUCT LABELING, "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." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THE SAMPLE WAS REQUESTED FOR A SAMPLE INTERFERENCE INVESTIGATION.THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T4 ASSAY RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 E601 MODULE AND A COBAS E 801 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6).FOR INFORMATION ON THE FT3 III RESULTS. THE T4 RESULT ON THE E601 ANALYZER WAS >320 NMOL/L. THE SAMPLE WAS TESTED ON ANOTHER LABORATORY'S E801 ANALYZER AND THE RESULT WAS 186 NMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE E601 ANALYZER SERIAL NUMBER (B)(4). THE OTHER LABORATORY'S E801 ANALYZER SERIAL NUMBER WAS REQUESTED BUT NOT PROVIDED.