ELECSYS CA 19-9 IMMUNOASSAY
Received Apr 22, 2025 · Event occurred Mar 18, 2025
Report 1823260-2025-01225 · MDR key 21881672
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
78239105
Product problems
- High Test Results
- Non Reproducible Results
- High Test Results
- Non Reproducible Results
Patient
46 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE COBAS E411 RACK 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 E411 RACK ANALYZER. THE INITIAL RESULT WAS 55.53 U/ML. THE REPEAT RESULTS WERE 0.979 U/ML AND 1.61 U/ML. ADDITIONAL RESULTS OF 0.200 NG/ML WITH A DATA FLAG AND 1.97 NG/ML WERE PROVIDED FROM THE DATE OF (B)(6) 2025. IT WAS UNCLEAR IF THESE RESULTS WERE ADDITIONAL REPEAT TESTS OF THE SAMPLE. CLARIFICATION WAS REQUESTED BUT HAS NOT YET BEEN PROVIDED. THE RESULT OF 0.979 U/ML WAS RELEASED DUE TO THE PATIENT'S CLINICAL CONDITION.
Additional Manufacturer Narrative
DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE QC BEFORE THE EVENT WAS WITHIN RANGE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.