BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3030411 · Received April 2, 2013

    Report

    Report Number
    1823260-2013-01968
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 19, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN ERROR WAS NOTED ON THE ANALYZER WHEN HE FIRST ARRIVED THAT MORNING. THE CUSTOMER THEN SMELLED AN ELECTRICAL SMELL AND SAW SMOKE COMING FROM THE TOP OF THE ANALYZER. HE THEN POWERED THE ANALYZER OFF. THE CUSTOMER NOTED THAT HE WAS THE ONLY PERSON IN THE LABORATORY AT THE TIME AND EVACUATION OF THE LABORATORY WAS NOT REQUIRED. THE CUSTOMER DID NOT INHALE ANY SMOKE AS HE POWERED THE ANALYZER OFF. NO ADVERSE EVENTS OCCURRED FOR THIS EVENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE CONTROLLER RACK WAS FAULTY. HE REPLACED THE CONTROLLER RACK AND AFFECTED ASSEMBLIES. HE OBSERVED PROPER OPERATION DURING INITIALIZATION. PROPER OPERATION WAS ALSO VERIFIED WITH CALIBRATION AND QUALITY CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135078 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1