ELECSYS CA 19-9 IMMUNOASSAY
Received May 5, 2025 · Event occurred Apr 14, 2025
Report 1823260-2025-01379 · MDR key 21960198
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
78239101
Product problems
- Non Reproducible Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS 6000 E601 MODULE SERIAL NUMBER WAS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FROM THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 132.6 U/ML AND THE REPEAT RESULT WAS 80.09 U/ML. ANOTHER SAMPLE TAKEN FROM THE SAME PATIENT AT THE SAME TIME HAD A RESULT OF 6.91 U/ML, AND THIS RESULT WAS BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE NOT RELEASED OUTSIDE OF THE LABORATORY.
Additional Manufacturer Narrative
DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM OR GENERAL REAGENT ISSUE IDENTIFIED.