CEA ELECSYS
Received Jul 20, 2018 · Event occurred Jul 4, 2018
Report 1823260-2018-02419 · MDR key 7706357
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsModel number
NACatalog number
11731629322
Lot number
244848
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 EVENT OCCURRED IN: (B)(6).
Description of Event or Problem
THE CUSTOMER COMPLAINED OF A QUESTIONABLE ELECSYS CEA ASSAY RESULT FROM 1 PATIENT SAMPLE TESTED ON A COBAS E 411 IMMUNOASSAY ANALYZER. THE INITIAL CEA RESULT WAS 9.38 NG/ML. ON (B)(6) 2018 A CEA RESULT OF 708.8 NG/ML WAS OBTAINED FROM A DIFFERENT PACK OF REAGENT. THE ERRONEOUS RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER STATED THAT THE ORIGINAL REAGENT PACK HAD MAGNETIC BEADS THAT WERE FROZEN WHICH THEY BELIEVED MIGHT HAVE CAUSED THE ERRONEOUS RESULT. THE COBAS E411 SERIAL NUMBER WAS (B)(4). THE INVESTIGATION IS CURRENTLY ONGOING.
Additional Manufacturer Narrative
THE CEA RESULT OF 708.8 NG/ML WAS DEEMED TO BE CORRECT.
Additional Manufacturer Narrative
THE INVESTIGATION DETERMINED THAT THE REASON FOR THE LOW RESULT WAS MOST LIKELY RELATED TO IMPROPER REAGENT HANDLING BY THE CUSTOMER. PRODUCT LABELING STATES THAT THE PRODUCT SHOULD BE STORED AT "2-8 DEGREES CELSIUS" AND "DO NOT FREEZE."