MalfunctionDHX
ARCHITECT CEA
Received Feb 17, 2016 · Event occurred Jul 29, 2015
Report 3008344661-2016-00008 · MDR key 5440755
Device
Generic name
Carcinoembryonic Antigen
Manufacturer
Abbott IrelandCatalog number
07K68-27
Lot number
UNKNOWN
Product problems
- High Test Results
Patient
73 YR
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED A FALSELY ELEVATED CEA RESULT ON A PATIENT. THE CEA RESULT FOR (B)(6) WAS 8.3. DUE TO THE CEA RESULT THE PATIENT HAD AN UNNECESSARY ENDOSCOPY PERFORMED WHICH WAS TOLERATED WELL WITH NO NEGATIVE OUTCOME.
Additional Manufacturer Narrative
THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE THE DEVICE WAS NOT PERFORMING AS INTENDED.