BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 25092768 · Received May 6, 2026

    Report

    Report Number
    1823260-2026-01761
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 15, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED FOR ALBUMIN AND UREA ON A COBAS 8000 C 702 MODULE. THE CUSTOMER STATED THAT FOR UREA, INITIAL RESULTS RANGED FROM 0.1 MMOL/L TO 0.5 MMOL/L, BUT UPON RETESTING, VALUES WERE OBSERVED BETWEEN 20 MMOL/L AND 50MMOL/L. FOR ALBUMIN, INITIAL RESULTED RANGED FROM 0.1 G/L TO 0.5 G/L, BUT UPON RETESTING, VALUES WERE OBSERVED BETWEEN 20 G/L AND 50 G/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168797 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1