ELECSYS CA 19-9
Received Aug 14, 2025 · Event occurred Jul 21, 2025
Report 1823260-2025-02491 · MDR key 22806063
Device
Generic name
Carbohydrate Antigen (ca19-9) Test System
Manufacturer
Roche DiagnosticsCatalog number
07027028190
Lot number
78240801
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
CALIBRATION AND QC WERE ACCEPTABLE. NO INSTRUMENT ALARMS WERE OBSERVED FOR THE CA 19-9 TEST. THE SAMPLE WAS RECEIVED FOR INVESTIGATION. THE CUSTOMER'S RESULTS WERE REPRODUCED DURING THE INVESTIGATION. THE SAMPLE WAS FURTHER INVESTIGATED USING A HETEROPHILIC BLOCKING TUBE (HBT) AND POLYETHYLENE GLYCOL (PEG). MACRO-PROTEIN AND HETEROPHILIC ANTIBODY INTERFERING FACTORS WERE IDENTIFIED. THIS INTERFERENCE IS ADDRESSED IN PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Additional Manufacturer Narrative
THE E801 ANALYZER SERIAL NUMBER WAS (B)(6). THE SAMPLE WAS REQUESTED FOR INVESTIGATION.
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A HIGH RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS CA 19-9 (CA 19-9) ON A COBAS E 801 ANALYTICAL UNIT. THE RESULT FROM THE E801 ANALYZER WAS 101 U/ML. THE REPEAT WAS 100 U/ML. THE SAMPLE WAS REPEATED BY AN UNSPECIFIED COMPETITOR METHOD, AND THE RESULT WAS 11.0 U/ML. THE RESULT OF 11.0 U/ML WAS BELIEVED TO BE CORRECT.