BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C 703 ANALYTICAL UNIT

    MDR report key: 24910891 · Received April 17, 2026

    Report

    Report Number
    1823260-2026-01472
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 17, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    07613336200544
    PMA / PMN Number
    K253490
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHOLESTEROL GEN.2 REAGENT LOT NUMBER WAS 934042. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER REPLACED THE FILTER AND THE NOZZLE TIPS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH CHOLESTEROL GEN.2 ASSAY ON A COBAS C 703 ANALYTICAL UNIT. INITIAL RESULT: 0.498 MMOL/L. REPEAT RESULT: 3.90 MMOL/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123688 COBAS C 703 ANALYTICAL UNIT ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE ROCHE DIAGNOSTICS 07613336200544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown