MalfunctionKQO
COBAS U 411 URINE ANALYZER
Received Dec 15, 2025 · Event occurred Nov 24, 2025
Report 1823260-2025-05105 · MDR key 23802034
Device
Product problems
- Data Problem
- Data Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER CONFIGURATION AND QC PERFORMANCE WERE VERIFIED AS CORRECT, AND THE BEHAVIOR COULD NOT BE REPRODUCED. DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED.
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A SAMPLE MISMATCH ON THE COBAS U 411 URINE ANALYZER. RESULTS WERE ASSIGNED TO THE WRONG SAMPLE (WRONG PATIENT ID). REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.