ELECSYS CA 19-9
Received Aug 13, 2025 · Event occurred Jul 23, 2025
Report 1823260-2025-02468 · MDR key 22792403
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
11776193122
Lot number
78239100
Product problems
- Low Test Results
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CALIBRATION WAS LAST PERFORMED ON 17-MAY-2025. THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE ALARM TRACE DID NOT CONTAIN A CONSPICUOUS EVENT. BASED ON THE CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH REAGENT PACK HANDLING ISSUES.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS CA 19-9 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 602 MODULE. THE INITIAL CA 19-9 RESULT FROM A 1:10 DILUTED SAMPLE WAS 12.12 U/ML. THE CUSTOMER QUESTIONED THE LOW RESULT AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND REPEATED THE SAMPLE. THE REPEAT RESULT FROM A 1:10 DILUTED SAMPLE WAS 9502 U/ML. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.