BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6800

    MDR report key: 8722387 · Received June 21, 2019

    Report

    Report Number
    2243471-2019-00024
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    June 17, 2019
    Report Date
    June 21, 2019
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    MZA
    PMA / PMN Number
    BK140196
    Removal / Correction Number
    2243471-06-06-2019-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS SOLVED BY REPLACING THE STOP DISCS AND O-RINGS ON THE CUSTOMER'S SYSTEM. ON 06-JUN-2019, LOCAL AFFILIATE ORGANIZATIONS WERE INFORMED THAT PROCESSING TRANSFER HEADS MAY BECOME UNTIGHT IN BETWEEN THE CURRENT PREVENTIVE MAINTENANCE INTERVALS, WHICH MAY CAUSE OCCURRENCES OF DROPLETS WITHIN THE PROCESSING MODULE. INSTRUCTIONS WERE PROVIDED TO THE LOCAL AFFILIATE ORGANIZATIONS TO REPLACE ALL O-RINGS AND STOP DISCS OF THE INSTALLED BASE, TAKING INTO CONSIDERATION INSTRUMENT USAGE AND INSTALLATION DATE. ADDITIONALLY CORRECTIVE AND PREVENTIVE MEASURES WILL BE IMPLEMENTED, AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER IN AUSTRALIA REPORTED TO OBSERVE LIQUID DROPLETS ON THEIR COBAS 6800/800 SYSTEMS PROCESSING MODULE DECK AND WITHIN THE HEATING STATIONS. A LOCAL FIELD SERVICE ENGINEER VISITED THE SITE, DECONTAMINATED THE SYSTEM, AND PERFORMED A TIGHTNESS CHECK, WHICH FAILED FOR SEVERAL POSITIONS. ALL O RINGS AND STOP DISCS WERE THEN REPLACED. THESE SERVICE ACTIVITIES REMEDIED THE CUSTOMER'S ALLEGATION. NO HARM OR INJURY WAS ALLEGED, NOR THE GENERATION OF ANY ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518876 COBAS 6800 AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT MZA ROCHE MOLECULAR SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1