ELECSYS T4 ASSAY
Received Jul 10, 2017 · Event occurred Jun 20, 2017
Report 1823260-2017-01411 · MDR key 6696387
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
12017709122
Lot number
188364
Product problems
- Incorrect Or Inadequate Test Results
- Incorrect Or Inadequate Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6). UNIQUE IDENTIFIER (UDI)#: (B)(4).
Description of Event or Problem
THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS T4 ASSAY (T4). IT IS NOT KNOWN IF ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER COMPLAINED THAT THERE WERE "HUGE DEVIATIONS" FOR 1 SAMPLE TESTED FOR T4. NO ACTUAL COMPARISON DATA WAS PROVIDED. ONE RESULT OF 24.86 UG/DL WAS PROVIDED. IT IS NOT KNOWN IF THIS WAS AN INITIAL RESULT OR A REPEAT RESULT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE INSTRUMENT TYPE AND SERIAL NUMBER WAS NOT PROVIDED. THE CUSTOMER LATER PROVIDED QUALITY CONTROL (QC) RESULTS WHICH INDICATED THAT THE T4 REAGENT EXPIRED ON 01/31/2017. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. SINCE NO ADDITIONAL INFORMATION WAS PROVIDED, THE INVESTIGATION COULD NOT BE COMPLETED.