ELECSYS CA 19-9
Received May 30, 2025 · Event occurred May 5, 2024
Report 1823260-2025-01672 · MDR key 22116019
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
782391
Product problems
- Low Test Results
- Non Reproducible Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 ON (B)(6) 2025 WAS <0.6 U/ML, AND THE REPEAT RESULT WAS 49.54 U/ML.
Additional Manufacturer Narrative
THE COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER IS (B)(6). THE LAST CALIBRATIONS PROVIDED WAS PERFORMED ON 01-AUG-2024, WHICH IS NOT THE RECOMMENDED INTERVAL. QC DATA WAS NOT PROVIDED. THE ALARM TRACE WAS NOT PROVIDED FOR THE DATE OF THE EVENT. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER (FSE) PERFORMED AN ARTIFICIAL MEDIA TEST (AM TEST), AND IT FAILED FOR DILUTION 1:20 PRECISION. DUE TO THIS ISSUE, THE SAMPLE PROBE WAS REPLACED, AND THE TEST WAS REPEATED. THE SECOND AM TEST PASSED COMPLETELY. THE ALARM TRACE THAT WAS PROVIDED WAS NOT FROM THE RANGE OF TIME OF THE EVENT. HOWEVER, THERE WERE SEVERAL OCCURRENCES OF SAMPLE QUALITY-RELATED ALARMS, SUCH AS INSUFFICIENT SAMPLE OR PIPETTE CLOG, WHICH IS CONSISTENT WITH PRE-ANALYTICAL ISSUES. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE.