ELECSYS CA 19-9
Received Mar 5, 2026 · Event occurred Feb 11, 2026
Report 1823260-2026-00784 · MDR key 24520823
Device
Generic name
Carbohydrate Antigen (ca19-9) Test System
Manufacturer
Roche DiagnosticsCatalog number
07027028190
Lot number
84908301
Product problems
- False Positive Result
- High Test Results
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- 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 8000 CORE UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 52.7 U/ML, AND THE REPEAT RESULT WAS <2 U/ML. THE QUESTIONABLE RESULT WAS NOT RELEASED OUTSIDE OF THE LABORATORY, AS THE CUSTOMER NOTICED THAT THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS AND REPEATED THE SAMPLE.
Additional Manufacturer Narrative
THE COBAS 8000 CORE UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative
MEDWATCH FIELD H6 INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION, AND COMPONENT CODE WERE UPDATED. IT WAS ALSO PROVIDED THAT THE CUSTOMER BELIEVES THAT THE REPEATED RESULT IS CORRECT BECAUSE THE PATIENT'S OTHER TUMOR MARKER RESULTS ARE NORMAL. THE INVESTIGATION DETERMINED THAT A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE QC PRIOR TO THE EVENT WAS WITHIN RANGES. IN THE ALARM TRACE, 2 SAMPLE FOAM ALARMS WERE DETECTED, AND ONE ABNORMAL ASPIRATION ALARM ON THE DAY OF THE EVENT. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.