BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 21415106 · Received February 19, 2025

    Report

    Report Number
    1823260-2025-00489
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 19, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    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 PSA LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) DETECTED INSUFFICIENT COMPONENT ADJUSTMENT ON THE MODULE'S GEAR PUMP HEAD (GPH) PRESSURE. THE FSE MADE ADJUSTMENTS TO THE GPH AND SIPPERS. AN INSTRUMENT CHECK AND A REAGENT CHECK WERE COMPLETED AND BOTH PASSED. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER SERVICE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE PROSTATE-SPECIFIC ANTIGEN (PSA) RESULT FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS <0.03 NG/ML, THE 1ST REPEAT RESULT WAS 4.12 NG/ML, THE 2ND REPEAT RESULT WAS <0.03 NG/ML, AND THE 3RD REPEAT RESULT WAS <0.03 NG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478175 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown