BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 2120976 · Received June 13, 2011

    Report

    Report Number
    1823260-2011-03192
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 25, 2011
    Report Date
    July 20, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE EVENT DETERMINED THE CAUSE WAS A CLEAR CUSTOMER HANDLING PROBLEM. THE CUSTOMER WAS CHANGING THE FUSE F3 WITHOUT SHUTTING DOWN THE ANALYZER FIRST AS REQUIRED BY PRODUCT LABELING. NO ONE WAS INJURED OR AFFECTED. NO ERRONEOUS TEST RESULTS WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED SHE WENT TO CHANGE THE F3 FUSE AND IT BLEW UP AND THERE WERE GLASS SHARDS IN THE FUSE HOLDER. THERE WERE NO ADVERSE AFFECTS TO THE CUSTOMER AS A RESULT OF THIS EVENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE OF THE EVENT WAS USER ERROR. THE CUSTOMER DID NOT DO A COMPLETE SHUTDOWN PRIOR TO CHANGING THE FUSE AS REQUIRED BY PRODUCT LABELING. HE REPLACED THE F3 FUSE HOLDER AND THE FUSE. HE POWERED UP THE ANALYZER WITH NO ERRORS. CUSTOMER RAN QUALITY CONTROL WITH RESULTS IN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1