ELECSYS FT3 III
Received Aug 23, 2023 · Event occurred Jul 25, 2023
Report 1823260-2023-02735 · MDR key 17603272
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsCatalog number
09043284190
Lot number
669112
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
AS NO SAMPLE MATERIAL COULD BE PROVIDED, FURTHER INVESTIGATION WAS NOT POSSIBLE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT A SUSPECTED INTERFERENCE FOR 1 PATIENT'S SAMPLE TESTED WITH ELECSYS FT4 IV ASSAY AND DISCREPANT RESULTS FOR THE SAME PATIENT'S SAMPLE TESTED WITH ELECSYS FT3 III ASSAY ON A COBAS E801 IMMUNOASSAY ANALYZER WHEN COMPARED TO NON-ROCHE PLATFORMS (ABBOTT AND SIEMENS). 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 FT4 IV ASSAY. FT4 IV RESULTS: INITIAL RESULT: MORE THAN 99 PMOL/L.. 1ST REPEAT RESULT: 18.8 PMOL/L (TESTED ON SIEMENS). 2ND REPEAT RESULT: 12.4 PMOL/L (TESTED ON ABBOTT). FT3 III RESULTS: INITIAL RESULT: 13.3 PMOL/L. 1ST REPEAT RESULT: 6.2 PMOL/L (TESTED ON SIEMENS). 2ND REPEAT RESULT: 4.2 PMOL/L (TESTED ON ABBOTT). THE QUESTIONABLE RESULT OF FT4 IV WAS NOT REPORTED OUTSIDE THE LABORATORY AS IT WAS CONSIDERED UNBELIEVABLE.
Additional Manufacturer Narrative
THE COBAS E801 IMMUNOANALYZER SERIAL NUMBER WAS (B)(6). INVESTIGATION IS ONGOING.