BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2802880 · Received October 24, 2012

    Report

    Report Number
    1823260-2012-05363
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 9, 2012
    Report Date
    December 18, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION OF THIS EVENT WAS POSSIBLE AS THE CUSTOMER HAS RETIRED THE ANALYZER AND WOULD NOT LET THE FIELD SERVICE REPRESENTATIVE EXAMINE IT. THIS ISSUE IS CONSISTENT WITH BEING DUE TO HEAT DAMAGE ON THE PLANAR WINDING PRINTED CIRCUIT BOARD CAUSED BY AN INSUFFICIENT COOLING AIR FLOW. THERE WAS NO RISK OF FIRE AND NO ONE WAS INJURED. ALL PARTS AND PLASTICS ARE UL RATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY HAD SPARKS FLYING OUT OF THE TOP LEFT CORNER OF THEIR INTEGRA 400 PLUS ANALYZER. THE FIRE DEPARTMENT CAME TO THE LABORATORY. THE INSTRUMENT WAS UNPLUGGED. THERE WAS AN ELECTRONIC SMELL, BUT NO SMOKE. NO ONE WAS INJURED AND NO ONE WAS TREATED FOR ANYTHING. THE CUSTOMER DECLINED A SERVICE VISIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1