MalfunctionKQO
COBAS U 601 URINE ANALYZER
Received May 27, 2026 · Event occurred May 5, 2026
Report 1823260-2026-02085 · MDR key 25303637
Device
Product problems
- Mechanics Altered
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION E3, OCCUPATION IS ROCHE FIELD SYSTEMS ENGINEER (FSE).
Description of Event or Problem
THERE WAS AN ALLEGATION OF AN ISSUE WITH THE SAMPLE PROBE WASH FUNCTIONALITY ON A COBAS U 601 URINE ANALYZER. THE CUSTOMER ALLEGED THAT WHEN PERFORMING AN AIR PURGE, THE SAMPLE PROBE DOES NOT MOVE INTO THE WASH STATION AND REMAINS AT THE TOP OF THE RINSE STATION. THE ANALYZER DOES NOT DISPLAY ANY ERROR MESSAGES. AN IMPROPERLY CLEANED SAMPLE PROBE COULD LEAD TO CROSS-CONTAMINATION, AFFECTING PATIENT SAMPLES.