BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3301221 · Received August 21, 2013

    Report

    Report Number
    1823260-2013-05072
    Event Type
    Malfunction
    Date Received
    August 21, 2013
    Date of Event
    August 8, 2013
    Report Date
    September 17, 2013
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THE INSTRUMENT IS RUNNING "GREAT" AFTER THE SERVICE VISIT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE. IT WAS NOTED THERE MAY HAVE BEEN A LOOSE CONNECTION (PLUG ABS LAMP TO PCB ABS MODULE) WHICH DAMAGED THE PARTS. WHEN AN ELECTRONIC PART GETS DAMAGED IT CAN CAUSE A BIT OF SMOKE AND ELECTRICAL SMELL. THE ISSUE WAS LOCALLY SOLVED BY THE REPLACEMENT OF THE PCB ABSORBANCE MODULE AND THE ABSORBANCE LAMP.

    Description of Event or Problem · 1

    THE CUSTOMER HAD JUST STARTED THE INTEGRA 400+ (I400+) TO BEGIN THE MORNING CALIBRATION AND QC. THE INSTRUMENT WAS INITIALIZING WHEN THE CUSTOMER NOTICED A STRONG BURNING SMELL. THE CUSTOMER STOPPED THE ANALYZER AND CHECKED FOR THE SOURCE OF THE BURNING SMELL, AND INDICATED IT WAS COMING FROM THE LAMP AREA. THE CUSTOMER TRIED TO REPLACE THE LAMP, BUT WAS UNABLE TO REMOVE THE PLUG FROM THE OLD LAMP AS IT WAS MELTED INTO THE CONNECTOR. THERE WERE NO INSTRUMENT ALARMS. THE CUSTOMER INDICATED THERE WAS NO SMOKE, NO VISIBLE SPARKS AND NO FLAMES. THE LABORATORY WAS NOT EVACUATED DUE TO THE BURNING SMELL AND NO ONE HAD TO SEEK MEDICAL ATTENTION. THE FIELD SERVICE REPRESENTATIVE FOUND AN ISSUE WITH THE ABSORBANCE PRINTED CIRCUIT BOARD MODULE. HE REPLACED THE BOARD AND PERFORMED QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405007 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1