ELECSYS CA 19-9
Received Aug 19, 2025 · Event occurred Jul 29, 2025
Report 1823260-2025-02549 · MDR key 22843872
Device
Generic name
Test, Carbohydrate Antigen (ca19-9)
Manufacturer
Roche DiagnosticsCatalog number
07027028188
Lot number
79417901
Product problems
- High Test Results
- Non Reproducible Results
- High 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 ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION DATA PROVIDED WAS ACCEPTABLE. THE ALARM TRACE DID NOT CONTAIN A CONSPICUOUS EVENT. IT WAS FOUND THAT THE CUSTOMER CENTRIFUGES PATIENT SAMPLES FOR 5 MINUTES. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CA 19-9 RESULT FOR 1 PATIENT SAMPLE TESTED ON A COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL CA 19-9 RESULT WAS 81.9 U/ML. THE FIRST REPEAT RESULT WAS 4.59 U/ML. THE SECOND REPEAT RESULT WAS 4.41 U/ML. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY, AS IT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS.
Additional Manufacturer Narrative
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.