BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 22157535 · Received June 6, 2025

    Report

    Report Number
    1823260-2025-01743
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 2, 2025
    Report Date
    July 1, 2025
    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 COBAS 8000 C702 MODULE SERIAL NUMBER IS (B)(6). ON THE FIELD SERVICE ENGINEER'S (FSE) INITIAL SERVICE VISIT, HE INSPECTED THE MODULE AND FOUND THE GEAR PUMP HEAD (GPH) PRESSURE LOW AND FLUCTUATING. HE REPLACED AND ADJUSTED THE GPH, WHICH RESOLVED THE ISSUE. HE ALSO CLEANED THE NOZZLES, ADJUSTED THE WASH LEVELS AND TUBINGS, CHECKED THE PROBE ALIGNMENTS, AND PERFORMED A SUCCESSFUL CELL BLANK. THE CUSTOMER PERFORMED SUCCESSFUL CALIBRATIONS AND QCS. ON THE FSE'S FOLLOW-UP SERVICE VISIT, HE FOUND A LEAK IN THE VALVE. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    MEDWATCH FIELDS D. DEVICE IDENTIFICATION, G1 AND G4 PMA/510K (PREMARKET NUMBERS) WERE UPDATED. THE ALBUMIN GEN.2 REAGENT LOT NUMBER IS 851293. THE CALIBRATION IS WITHIN THE SPECIFIED RANGES. THE QCS WERE WITHIN THE +/- 2 STANDARD DEVIATION RANGE. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE, ADJUSTED THE GEAR PUMP HEAD PRESSURE, CLEANED AND REPAIRED THE NOZZLE IN THE WASH STATION, ADJUSTED THE RINSE LEVELS OF THE CUVETTES AND DETERGENTS, REPAIRED THE DRIPPING IN THE RINSE STATION AND RINSE NOZZLE, REPLACED THE SOLENOID VALVES, PERFORMED PRIMES AND PURGES, AND CONDUCTED SUCCESSFUL MECHANICAL CHECKS. A GENERAL REAGENT OR ANALYZER PROBLEM IS UNLIKELY BECAUSE THE CALIBRATION AND QC ARE ACCEPTABLE. THE EVENT'S SPECIFIC CAUSE COULD NOT BE DETERMINED THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED QUESTIONABLE ALBUMIN GEN.2 ASSAY RESULTS FROM FOUR PATIENT SAMPLES TESTED ON THE COBAS 8000 C702 MODULE. ON (B)(6) 2025: PATIENT SAMPLE 1: THE INITIAL RESULT WAS 66.8 G/L OR 67 G/L WITH A DATA FLAG. THE REPEAT RESULT WAS 38.6 G/L. THE REPEAT RESULT WAS 38.8 G/L. ON (B)(6) 2025: PATIENT SAMPLE 2: THE INITIAL RESULT WAS 99.2 G/L. THE REPEAT RESULT WAS 34.9 G/L WITH A DATA FLAG. ON (B)(6) 2025: PATIENT SAMPLE 3: THE INITIAL RESULT WAS 63.27 G/L WITH A DATA FLAG. THE REPEAT RESULT WAS 26.3 G/L. THE REPEAT RESULT WAS REPORTED OUTSIDE THE LABORATORY. ON (B)(6) 2025: PATIENT SAMPLE 4: THE INITIAL RESULT WAS 192.46 G/L WITH A DATA FLAG. THE REPEAT RESULTS WERE 29.6 G/L AND 25.42 G/L. THE REPEAT RESULT OF 29.6 G/L WAS REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718657 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 851293

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female