BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS U 601 URINE ANALYZER

    MDR report key: 24221540 · Received January 30, 2026

    Report

    Report Number
    1823260-2026-00317
    Event Type
    Malfunction
    Date Received
    January 30, 2026
    Date of Event
    January 6, 2026
    Report Date
    April 15, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    KQO
    UDI-DI
    04015630932443
    PMA / PMN Number
    K183432
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS U PACK URINE TEST STRIPS LOT NUMBER USED WAS 86552500 WITH AN EXPIRATION DATE OF 30-APR-2026. THE QC OBTAINED EXPECTED RESULTS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE REQUESTED PICTURES AND DATA WERE PROVIDED FOR THE INVESTIGATION. THE INVESTIGATION WAS PERFORMED AS FOLLOWS: THE RETENTION MATERIAL OF THE COBAS U PACK URINE TEST STRIPS, LOT NUMBER 86552500, WAS MEASURED ON A COBAS U 601 URINE ANALYZER WITH MATERIAL OF BIORAD LIQUICHECK LEVEL 2, LOT NUMBER 98052, AND MATERIAL OF BIORAD QUANTIFY PLUS LEVEL 2, LOT NUMBER 1002552. THE RETENTION MATERIAL OF THE COBAS U CUVETTE, LOT NUMBER 24103600, WAS MEASURED ON A COBAS U 701 ANALYZER WITH MATERIAL OF BIORAD LIQUICHECK LEVEL 2, LOT NUMBER 98052, AND MATERIAL OF BIORAD QUANTIFY PLUS LEVEL 2, LOT NUMBER 1002552. THE INVESTIGATION RESULTS WERE: NO FALSE NEGATIVE RESULTS ON THE COBAS U 601 URINE ANALYZER WERE OBSERVED. THE RESULTS FOR LEUKOCYTES FROM THE COBAS U 601 URINE ANALYZER AND U 701 ANALYZER WERE COMPARABLE. ALL MEASUREMENTS FULFILLED THE REQUIREMENTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT A QUESTIONABLE NEGATIVE RESULT NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED WITH COBAS U PACK URINE TEST STRIP ON A COBAS U 601 URINE ANALYZER. THE SAMPLE WAS TESTED ON THE COBAS U 601 URINE ANALYZER AND OBTAINED A NEGATIVE LEU (LEUCOCYTES) RESULT. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL DIAGNOSIS, PROMPTING THE CUSTOMER TO EXAMINE THE SAMPLE MICROSCOPICALLY AND OBSERVE NEUTROPHILS, SUGGESTING A POSITIVE RESULT. NO QUESTIONABLE RESULT WAS RELEASED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362797 COBAS U 601 URINE ANALYZER AUTOMATED URINE ANALYZER KQO ROCHE DIAGNOSTICS 04015630932443

    Patients

    Seq Age Sex Outcome Treatment
    1