ELECSYS T4 ASSAY
Received Oct 30, 2018 · Event occurred Oct 9, 2018
Report 1823260-2018-03894 · MDR key 8018332
Device
Generic name
Radioimmunoassay, Total Thyroxine
Manufacturer
Roche DiagnosticsModel number
NACatalog number
07027885190
Lot number
287093
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
15 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS T4 ASSAY ON A COBAS 8000 E 801 MODULE. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS TESTED THREE TIMES ON THE CUSTOMER'S E 801 ANALYZER, RESULTING WITH T4 VALUES OF 24.4 UG/DL, 24.9 UG/DL ACCOMPANIED BY A DATA FLAG, AND 21.6 UG/DL. THE SAMPLE WAS TESTED AT ANOTHER LABORATORY ON A COBAS 6000 E 601 MODULE, RESULTING WITH A T4 VALUE OF 12.21 UG/DL. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE CUSTOMER'S E 801 ANALYZER IS (B)(4). THE SERIAL NUMBER OF THE E 601 ANALYZER USED AT THE OTHER LABORATORY WAS ASKED FOR, BUT NOT PROVIDED.
Additional Manufacturer Narrative
A SAMPLE WAS PROVIDED FOR INVESTIGATION. AN INTERFERING FACTOR AGAINST A COMPONENT OF THE REAGENT WAS IDENTIFIED. THIS INTERFERENCE IS ADDRESSED IN THE PACKAGE INSERT.