ELECSYS CA 19-9
Received Jun 18, 2025 · Event occurred May 21, 2025
Report 1823260-2025-01887 · MDR key 22284499
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028214
Lot number
820906
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
PREVENTIVE MAINTENANCE WAS PERFORMED ON THE ANALYZER, INCLUDING EXCHANGE OF THE MEASURING CELL, GEAR PUMP, AND SYRINGE SEAL. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE E801 ANALYZER IS (B)(6). CALIBRATION AND CONTROLS WERE ACCEPTABLE. ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY. A REVIEW OF THE ALARM TRACE DATA SHOWED NO RELEVANT ALARMS. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS CA 19-9 AND COBAS E 801 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A CA 19-9 VALUE OF 53.8 U/ML. THE PATIENT'S PREVIOUS VALUE WAS AROUND 25 U/ML, SO THE CUSTOMER DECIDED TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED FOUR TIMES, RESULTING IN VALUES OF 28.1 U/ML, 28.5 U/ML, 27.8 U/ML, AND 28.3 U/ML.