ELECSYS CA 19-9 IMMUNOASSAY
Received Mar 5, 2025 · Event occurred Feb 10, 2025
Report 1823260-2025-00633 · MDR key 21526381
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
782391
Product problems
- High Test Results
- Insufficient Device Problem Information
- Non Reproducible Results
- High Test Results
- Insufficient Device Problem Information
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DUE TO THE LIMITED INFORMATION AVAILABLE ABOUT THE ISSUE, A DIRECT ROOT CAUSE COULD NOT BE DETERMINED.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS 6000 E601 MODULE. ON (B)(6) 2025 THE INITIAL RESULT WAS 42.92 U/ML, AND THE REPEAT RESULT WAS 17.84 U/ML. THE QUESTIONABLE RESULT WAS NOT RELEASED OUTSIDE OF THE LAB AND THE REPEAT RESULT WAS DEEMED TO BE CORRECT. ON (B)(6) 2025 THE INITIAL RESULT WAS 162.4 U/ML, AND THE REPEAT RESULTS WERE 17.05 U/ML, 11.73 U/ML, AND 12.4 U/ML. ON (B)(6) 2025 THE INITIAL RESULT WAS 28.45 U/ML, AND THE REPEAT RESULTS WITH A DIFFERENT REAGENT PACK WERE 6.45 U/ML, 6.27 U/ML, AND 6.27 U/ML.
Additional Manufacturer Narrative
THE COBAS 6000 E601 MODULE SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.