BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 303 ANALYTICAL UNIT

    MDR report key: 23979505 · Received January 6, 2026

    Report

    Report Number
    1823260-2026-00068
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 12, 2025
    Report Date
    February 4, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) EXCHANGED A DEFECTIVE SAMPLE PROBE. FOLLOWING THE FSE INTERVENTION, NO FURTHER ISSUE WAS OBSERVED. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 882312. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE HK GEN.3 RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.97 MG/DL. THE REPEAT RESULT WAS 110 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490578 COBAS C 303 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Female ENOXAPARIN SC 40 MG EVERY 24 HOURS