ELECSYS CA 125 II
Received May 30, 2025 · Event occurred May 6, 2024
Report 1823260-2025-01673 · MDR key 22116017
Device
Generic name
Test, Epithelial Ovarian Tumor-associated Antigen (ca125)
Manufacturer
Roche DiagnosticsCatalog number
11776223190
Lot number
823966
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
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.
Additional Manufacturer Narrative
THE COBAS E 411 ANALYZER (DISK SYSTEM) SERIAL NUMBER IS (B)(4). QC AND CALIBRATION DATA WERE NOT PROVIDED. THE ALARM TRACE SHOWS SEVERAL OCCURRENCES OF INSUFFICIENT SAMPLE OR PIPETTE CLOG, WHICH IS CONSISTENT WITH A PRE-ANALYTICAL ISSUE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 125 II 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 20.31 U/ML.