ELECSYS T4
Received Dec 20, 2023 · Event occurred Dec 5, 2023
Report 1823260-2023-04138 · MDR key 18365980
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsCatalog number
ASKU
Lot number
711668
Product problems
- High Test Results
- Chemical Problem
- High Test Results
- Chemical Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION D4 REAGENT LOT NUMBER HAS BEEN UPDATED. THE CUSTOMER'S T4 REFERENCE RANGE IS 5.1-14.1 UG/DL. THE CUSTOMER STATED THAT THEIR QC RECOVERY DATA WAS ACCEPTABLE. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS T3, ELECSYS T4 ASSAY, AND ELECSYS TSH ASSAY RESULTS FOR 6 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT COMPARED TO TREE COMPETITOR ANALYZERS. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE T3 RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH RESULTS. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. THE UNITS OF MEASUREMENT FOR THE TSH RESULTS AND FOR THE COMPETITOR ANALYZER RESULTS WERE NOT PROVIDED. THE REFERENCE RANGES FOR ALL ASSAYS WERE NOT PROVIDED.