ELECSYS CA 19-9 IMMUNOASSAY
Received Jun 10, 2025 · Event occurred May 14, 2025
Report 1823260-2025-01785 · MDR key 22176056
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
782391
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Low Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- Low 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 COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER IS (B)(6). QC WAS IN RANGE ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 RESULT FROM THE COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 7.4 IU/ML. THE PATIENT WAS RETESTED AT ANOTHER LAB WITH A RESULT OF 940 IU/ML. THE INITIAL SAMPLE WAS RETESTED, AND THE REPEAT RESULT WAS 710 IU/ML.
Additional Manufacturer Narrative
THE INITIAL RESULT REPORTED WAS APPROXIMATE. THE EXACT INITIAL RESULT OF 7.54 U/ML WAS PROVIDED. ANOTHER REPEAT RESULT OF 926.5 U/ML FROM THE REPORTED COBAS E 411 WAS PROVIDED. THE CALIBRATION AND QC DATA PROVIDED WERE SEVERAL DAYS AFTER THE EVENT. THE CUSTOMER HAS HAD SEVERAL QC POINTS OUT OF RANGE, WHICH CAN INDICATE THAT THERE MIGHT BE A GENERAL QC HANDLING ISSUE OR AN INSTRUMENT ISSUE PRESENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE.