BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 402 ANALYTICAL UNIT

    MDR report key: 25092766 · Received May 6, 2026

    Report

    Report Number
    1823260-2026-01756
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 11, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLGF REAGENT LOT NUMBER WAS 900555 WITH AN EXPIRATION DATE OF 31-DEC-2026. THE ANALYZER HAD BEEN IN RACK RECEPTION MODE SINCE (B)(6) 2026. NO PATIENT SAMPLES WERE MEASURED DURING THIS TIME PERIOD; HOWEVER, THE SYSTEM REMAINED POWERED ON AND IN OPERATIONAL STATUS. ON (B)(6) 2026, QC RESULTS WERE LOWER THAN EXPECTED. THE ANALYZER WAS PLACED INTO STANDBY MODE AND RESTARTED. FOLLOWING THE RESTART, QC RESULTS WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO INSUFFICIENT SYSTEM WATER SUPPLY TO THE FLUIDIC ASSEMBLIES AFTER PROLONGED INACTIVITY. THE MAIN WATER PUMP PRESSURE WAS LOW. WHEN THE OPERATION RESUMES AFTER AN EXTENDED PERIOD, REDUCED MAIN PUMP OUTPUT MAY PREVENT ADEQUATE WATER SUPPLY TO THE GEAR PUMP. AS SOLENOID VALVES OPEN DURING MEASUREMENT CYCLES, WATER MAY THEN BE DRAWN FROM THE SYRINGE ASSEMBLIES, CAUSING UNSTABLE FLUIDICS AND QUESTIONABLE RESULTS.

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PLGF (PLGF) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL PLGF RESULT WAS 71.6 PG/ML. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 304 PG/ML AND 306 PG/ML. THE SAMPLE WAS REPEATED DUE TO A DATA FLAG ON A DIFFERENT PARAMETER. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168796 COBAS E 402 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E402

    Patients

    Seq Age Sex Outcome Treatment
    1