ELECSYS FT3 III
Received Mar 23, 2023 · Event occurred Feb 7, 2023
Report 1823260-2023-00935 · MDR key 16600168
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005803190
Lot number
623234
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
QUALITY CONTROLS WERE ACCEPTABLE AND A GENERAL REAGENT PROBLEM CAN BE EXCLUDED. INSTRUMENT PERFORMANCE DATA IS WITHIN SPECIFICATIONS. UPON REVIEW OF THE ALARM TRACE, AN "ABNORMAL PROBE SUCKING" ALARM WAS OBSERVED NEAR THE TIMEPOINT OF MEASURING THE SECOND PATIENT SAMPLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ISSUE IS CONSISTENT WITH A PREANALYTICAL HANDLING ISSUE.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR SAMPLES FROM TWO PATIENTS TESTED WITH THE ELECSYS FT3 III ASSAY ON A COBAS 6000 E601 MODULE, SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. PATIENT 1: THE SAMPLE INITIALLY RESULTED IN AN FT3 III VALUE OF 39.18 PMOL/L. ON (B)(6) 2023, A NEW SAMPLE FROM THE PATIENT RESULTED IN AN FT3 III VALUE OF 4.54 PMOL/L. PATIENT 2: THE SAMPLE INITIALLY RESULTED IN AN FT3 III VALUE OF 42.21 PMOL/L. ON (B)(6) 2023, A NEW SAMPLE FROM THE PATIENT RESULTED IN AN FT3 III VALUE OF 4.95 PMOL/L.