ELECSYS FT3 III
Received Apr 17, 2024 · Event occurred Mar 26, 2024
Report 1823260-2024-01187 · MDR key 19125670
Device
Generic name
Total Triiodothyronine
Manufacturer
Roche DiagnosticsModel number
FT3 IIICatalog number
09005811190
Lot number
744598
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 COBAS E801 SERIAL NUMBER WAS (B)(6) . THE SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR 1 PATIENT¿S SAMPLE TESTED WITH ELECSYS FT3 G3 V2 (FT3 III V2) ASSAY ON A COBAS 8000 E801 MODULE COMPARED TO A NON-ROCHE ANALYZER (SN (B)(6). REFER TO THE ATTACHMENT FOR THE PATIENT¿S DATA. ON (B)(6) 2024 THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E801 ANALYZER. THE RESULTS DID NOT MATCH THE PATIENT'S CLINICAL SYMPTOMS AND, THEREFORE, THE SAMPLE WAS THEN REPEATED ON A NON-ROCHE ANALYZER (SN (B)(6). THE SAMPLE WAS ALSO REPEATED ON A ROCHE ANALYZER AND THE REPEAT RESULTS WERE THE SAME AS THE INITIAL RESULTS.
Additional Manufacturer Narrative
THE SAMPLE WAS NOT PROVIDED FOR INVESTIGATION. THE DATA WAS NOT PROVIDED FOR INVESTIGATION. 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.