ELECSYS CA 19-9
Received Apr 1, 2025 · Event occurred Mar 7, 2025
Report 1823260-2025-00947 · MDR key 21738212
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028188
Lot number
79417901
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
THE ALARM TRACE SHOWED 2 "SAMPLE CLOT DETECTION" ALARMS ON (B)(6) 2025. A GENERAL REAGENT PROBLEM CAN BE EXCLUDED BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE COBAS E801 ANALYTICAL UNIT SERIAL NUMBER WAS (B)(6). THE QC WAS PROVIDED FROM 01-FEB-2025 TO 28-FEB-2025 AND IT WAS WITHIN RANGE. THE FIELD SERVICE ENGINEER RETESTED 2 RANDOM SAMPLES WITH HIGH RESULTS AND THE REPEAT RESULTS WERE ALSO HIGH. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS CARBOHYDRATE ANTIGEN 19-9 (CA 19-9) ASSAY ON A COBAS E801 ANALYTICAL UNIT. INITIAL RESULT: 114 U/ML. THE CUSTOMER NOTICED THAT THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY AND THE SAMPLE WAS REPEATED. REPEAT RESULT: 2.00 U/ML (ACCOMPANIED BY A DATA FLAG). THE REPEAT RESULT WAS DEEMED TO BE CORRECT.