ELECSYS CA 19-9
Received Aug 29, 2025 · Event occurred Jul 31, 2025
Report 1823260-2025-02663 · MDR key 22921979
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028188
Lot number
82090603
Product problems
- False Positive Result
- High Test Results
- Non Reproducible Results
- False Positive Result
- High Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 38.0 U/ML. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 16.7 U/ML AND 17.9 U/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025. THE ALARM TRACE SHOWED FOUR SAMPLE CLOT DETECTION ALARMS ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.