BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 24236970 · Received February 2, 2026

    Report

    Report Number
    1823260-2026-00349
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    January 12, 2026
    Report Date
    April 13, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GLUCOSE HK GEN.3 REAGENT LOT NUMBER IS 882312. THE EXPIRATION DATE WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE REPRESENTATIVE (FSR) INSPECTED THE ANALYZER AND REPLACED THE GEAR PUMP HEADS, REAGENT, SAMPLE PROBE, AND A SOLENOID VALVE. HE ALSO COMPREHENSIVELY CLEANED THE ENTIRE SYSTEM WITH BLEACH AND ADJUSTED ALL MECHANICAL COMPONENTS. HE VERIFIED THE ANALYZER'S PERFORMANCE WITH SUCCESSFUL TEST RUNS AND QCS. THE INVESTIGATION DETERMINED THAT MECHANICAL FAILURE OF THE GEAR PUMPS AND SOLENOID VALVE, CONTAMINATION OF THE SYSTEM, AND WORN REAGENT AND SAMPLE PROBES CAUSED THE EVENT. THE CUSTOMER HAS NOT REPORTED ANY OTHER ISSUES AFTER THE SERVICE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS C 303 ANALYTICAL UNIT. PATIENT SAMPLE 1 THE INITIAL RESULT WAS 3 MG/DL. THE REPEAT RESULT WAS 143 MG/DL. PATIENT SAMPLE 2 THE INITIAL RESULT WAS 4 MG/DL. THE REPEAT RESULT WAS 218 MG/DL. THE INITIAL RESULTS WERE DEEMED INCORRECT AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7029 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown