ELECSYS CEA ASSAY
Received Jul 14, 2021 · Event occurred Jun 24, 2021
Report 1823260-2021-02016 · MDR key 12165198
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsModel number
NACatalog number
ASKU
Lot number
529597
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
59 YR
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INSTRUMENT CHECK WAS PERFORMED AND WAS WITHIN SPECIFICATIONS. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
OTHER TEXT : NA.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR SEVEN PATIENT SAMPLES TESTED WITH THE ELECSYS CEA ASSAY ON A COBAS 8000 E 801 MODULE. SAMPLES WERE REPEATED AFTER SWITCHING TO A NEW REAGENT PACK AND DISCREPANCIES WERE OBSERVED. FOR THE FIRST AND SECOND SAMPLES, THE RESULTS MEASURED WITH THE OLD REAGENT PACK WERE REPORTED OUTSIDE OF THE LABORATORY. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY FOR SAMPLES 3-7. THE FIRST SAMPLE WAS ALSO REPEATED USING THE NEW REAGENT PACK AFTER RE-CENTRIFUGATION. THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).