MalfunctionKQO

COBAS U 411 URINE ANALYZER

Received Jun 11, 2026 · Event occurred May 20, 2026

Report 1823260-2026-02312 · MDR key 25475097

Device

Generic name

Automated Urinalysis System

Manufacturer

Roche Diagnostics

Catalog number

04906969001

Product problems

Computer Operating System Problem

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF A PATIENT SAMPLE MISMATCH ON A COBAS U 411 URINE ANALYZER. THE CUSTOMER ALLEGED THAT THERE WAS A SAMPLE MISMATCH WITH "SOME" SAMPLES. NO SAMPLE IDS WERE PROVIDED.