ELECSYS CA 19-9
Received Apr 25, 2025 · Event occurred Apr 4, 2025
Report 1823260-2025-01278 · MDR key 21908218
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028214
Lot number
ASKU
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
73 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CA 19-9 (CA 19-9) ON A COBAS 8000 E 801 MODULE. THE INITIAL RESULT WAS 565 U/ML. THE REPEAT WITH A 1:2 DILUTION WAS 815 U/ML. THE REPEAT WITH A 1:10 DILUTION WAS 796 U/ML. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION AND TESTED ON AN E801 MODULE. THE INITIAL RESULT WAS 589 U/ML. THE REPEAT WITH A 1:2 DILUTION WAS 874 U/ML. THE REPEAT WITH A 1:5 DILUTION WAS 1285 U/ML. THE REPEAT WITH A 1:10 DILUTION WAS 1530 U/ML. THE INVESTIGATION SITE SENT THE SAMPLE TO AN OUTSOURCED LABORATORY USING A COMPETITOR METHOD, AND THE CA 19-9 RESULT WAS 679 U/ML.
Additional Manufacturer Narrative
THE CUSTOMER¿S E801 MODULE SERIAL NUMBER WAS (B)(6). THE COMPETITOR METHOD WAS FUJIREBIO LUMIPULSE.
Additional Manufacturer Narrative
THE SAMPLE WAS INVESTIGATED FURTHER AT THE INVESTIGATION SITE. THE INITIAL CA 19-9 RESULT WAS 585 U/ML. THE REPEAT WITH A 1:2 DILUTION WAS 824 U/ML. THE REPEAT WITH A 1:10 DILUTION WAS 1406 U/ML. THIS RESULT CONFIRMS THE 1:10 DILUTION RESULT PRODUCED DURING THE PRELIMINARY INVESTIGATION. THE LOW UNDILUTED RESULTS ARE CONSISTENT WITH AN UNKNOWN INTERFERING SUBSTANCE OR FACTOR. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.