BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 402 ANALYTICAL UNIT

    MDR report key: 21573644 · Received March 11, 2025

    Report

    Report Number
    1823260-2025-00698
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 21, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE WAS FOUND TO BE CONSISTENT WITH CUSTOMER MAINTENANCE BEING OVERDUE AS THE ISSUE WAS RESOLVED AFTER THE SIPPER FLOW PATH WAS CLEANED AND CONDITIONING WAS COMPLETED. THESE MAINTENANCE ACTIONS ARE THE RESPONSIBILITY OF THE CUSTOMER. THE OVERDUE CALIBRATION CAN BE EXCLUDED AS THE ROOT CAUSE AS THERE WOULD BE MORE THAN ONE QUESTIONABLE RESULT.

    Additional Manufacturer Narrative · 0

    THE ELECSYS HCG+SS LOT NUMBER IS 792314 AND THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER CLEANED ACCUMULATED DUST AND SERUM FROM THE DEVICE SURFACE, CLEANED THE WASH STATIONS, THE REAGENT PROBES, THE SAMPLE PROBE, AND SIPPERS. THEY CLEANED THE MIXER AND PERFORMED A CHECK TO ENSURE THAT THERE WERE NO BUBBLES FORMED. THEY PERFORMED A SIPPER FLOW PATH AND CONDITIONING. A QC CHECK PASSED AND THEY RAN THE AFFECTED SAMPLE ON THE SAME ANALYZER 5 TIMES AND RECEIVED SIMILAR CORRECT RESULTS WITHOUT ALARMS. THE LAST CALIBRATION WAS COMPLETED OVER MORE THAN ONE MONTH AGO. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG+SS RESULT THE COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 2.89 MIU/ML, AND THE REPEAT RESULT WAS 146 MIU/ML. THE REPEAT RESULT IS CONSIDERED TO BE CORRECT COMPARED TO THE RESULTS FROM AN AT HOME RAPID TEST HCG STRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221663 COBAS E 402 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown