THYROXINE
Received May 20, 2011 · Event occurred Apr 24, 2011
Report 1823260-2011-02621 · MDR key 2098156
Device
Generic name
Radioassay, Triiodothyronine Uptake
Manufacturer
Roche DiagnosticsModel number
NACatalog number
12017709160
Lot number
16138601
Product problems
- High Test Results
Patient
064 YR
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(6).
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THE CAUSE TO BE THE LEAKING DETECTION UNIT WHICH WAS DISCOVERED BY THE FIELD SERVICE REPRESENTATIVE. HE FOUND LIQUID HAD LEAKED ON A PCB BOARD AND CHANGED THE BOARD. THE ISSUE WAS SOLVED BY THE REPLACEMENT OF THE WHOLE DETECTION UNIT. NO PATIENTS WERE AFFECTED IN ANY WAY.
Description of Event or Problem
THE USER RECEIVED QUESTIONABLE T4 RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES FROM THE COBAS E601 ANALYZER SERIAL NUMBER (B)(4). OF THE PROVIDED DATA, THE RESULT FOR ONE PATIENT SAMPLE WAS DISCREPANT AND REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULT WAS 24.86 UG/DL AND THE REPEAT RESULT ON (B)(6) 2011 WAS 10.33 UG/DL. NO ADVERSE EVENTS WERE ALLEGED REGARDING THE ISSUE. UPON EVALUATION OF THE ANALYZER, THE FIELD SERVICE REPRESENTATIVE DETERMINED THE DETECTION UNIT WAS DAMAGED DUE TO FLUID. HE REPLACED THE DETECTION UNIT AND VERIFIED THE ANALYZER OPERATION BY RUNNING PERFORMANCE TESTING WITH RESULTS WITHIN SPECIFICATIONS.