BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 402 ANALYTICAL UNIT

    MDR report key: 21092087 · Received January 7, 2025

    Report

    Report Number
    1823260-2025-00045
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 19, 2024
    Report Date
    January 7, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K220134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 792314. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND THERE WAS POOR RINSE, POOR REAGENT PROBE ADJUSTMENT, THE BEAD MIXER WAS BENT, AND THERE WAS DUST/CONTAMINATION NEAR THE ASSAY CUPS/TIPS AREA. HE REPLACED THE REAGENT PROBE, SAMPLE PROBES, AND THE BEAD MIXER. THE INVESTIGATION COULD NOT IDENTIFY A SPECIFIC ROOT CAUSE. THE ISSUE APPEARED TO BE RESOLVED AFTER THE SERVICE ACTIONS.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS HCG+B RESULT FROM THE COBAS PURE E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1500 MIU/ML AND WAS QUESTIONED BY THE PHYSICIAN. THE REPEAT RESULT FROM ANOTHER COBAS PURE ANALYZER WAS 51000 MIU/ML. THE REPEAT RESULT FROM THE ORIGINAL ANALYZER WAS 1500 MIU/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835417 COBAS E 402 ANALYTICAL UNIT CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown