ELECSYS CEA
Received Aug 13, 2024 · Event occurred Jul 18, 2024
Report 1823260-2024-02352 · MDR key 19974494
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsCatalog number
11731629322
Lot number
74942501
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E411 ANALYZER IS (B)(6). THE CUSTOMER STATED THAT CONTROL RECOVERY WAS STABLE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CEA ON A COBAS E411 DISK. THE SAMPLE INITIALLY RESULTED IN A CEA VALUE OF 5.5 NG/ML. THE SAMPLE WAS REPEATED TWICE, RESULTING IN CEA VALUES OF 3.2 NG/ML AND 3.2 NG/ML. THE SAMPLE WAS ALSO REPEATED USING A SECOND REAGENT PACK THAT WAS LOADED ON THE ANALYZER AND IT RESULTED IN A VALUE OF 3.2 NG/ML.
Additional Manufacturer Narrative
A GENERAL REAGENT ISSUE CAN BE RULED OUT AS CALIBRATION AND CONTROLS WERE ACCEPTABLE. ISOLATED NON-REPRODUCIBLE RESULTS ALSO DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. UPON REVIEW OF THE ALARM TRACE, NO ABNORMALITIES WERE OBSERVED ON THE DAY OF THE EVENT. THE SAMPLE COAGULATION TIME AND CENTRIFUGATION TIME WERE SHORTER THAN RECOMMENDED BY THE TUBE MANUFACTURER. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. THE ISSUE IS CONSISTENT WITH INSUFFICIENT PRE-ANALYTIC SAMPLE HANDLING.