ELECSYS CEA ASSAY
Received Nov 26, 2018 · Event occurred Oct 31, 2018
Report 1823260-2018-04480 · MDR key 8103492
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11731629322
Lot number
355404
Product problems
- Low Test Results
- Low Test Results
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THIS EVENT OCCURRED IN (B)(6).
Description of Event or Problem
THE CUSTOMER RECEIVED A QUESTIONABLE LOW ELECSYS CEA ASSAY RESULTS FOR ONE PATIENT SAMPLE FROM TWO COBAS 6000 E 601 MODULES. THE SERIAL NUMBERS WERE (B)(4). IT WAS UNCLEAR WHICH ANALYZER GENERATED WHICH SPECIFIC RESULT. THE INITIAL RESULT WAS LESS THAN 1.0 UG/L AND WAS REPORTED OUTSIDE OF THE LABORATORY. THE PHYSICIAN DID NOT BELIEVE THE RESULT AND THE SAMPLE WAS REPEATED. THE REPEAT RESULTS WERE 0.267 UG/L, 17.69 UG/L, AND 17.77 UG/L. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE FIELD SERVICE REPRESENTATIVE CHECKED THE INSTRUMENTS AND PERFORMED A SYSTEM VOLUME CHECK. ON COBAS E601 SERIAL NUMBER (B)(4), HE FOUND THE BRANCH BLOCK HAD A SLIGHT LEAK AND HE REPLACED THE BRANCH BLOCK AND PINCH TUBE. HE PERFORMED A SIPPER PURGE.