BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3071357 · Received April 22, 2013

    Report

    Report Number
    1823260-2013-02462
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 14, 2013
    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

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT DETERMINE A SPECIFIC ROOT CAUSE AS THE AFFECTED POWER BOX WAS DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION PURPOSES. BASED UPON THE INFORMATION PROVIDED FOR INVESTIGATION, IT IS ASSUMED INSUFFICIENT COOLING OR AN UNEXPECTED FAILURE OF AN ELECTRONIC COMPONENT WAS THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY SMELLED A "BAD SMELL" COMING FROM THE BACK OF THE ANALYZER. THE CUSTOMER THEN SAW BLACK SMOKE COMING OUT OF THE LEFT SIDE OF THE REAR OF THE ANALYZER. THE ANALYZER WAS TURNED OFF AND EVERYONE LEFT THE ROOM. THERE WERE NO ONE WAS HURT OR INJURED DUE TO THE SMOKE. THE CUSTOMER STATED THERE WAS AN INSTRUMENT ALARM, BUT DID NOT CHECK THE ALARM AS SHE COULD SEE THE SMOKE AT THAT POINT AND JUST TURNED OFF THE ANALYZER. THE FIELD SERVICE REPRESENTATIVE FOUND THAT THERE WAS A BAD POWER SUPPLY. HE REPLACED THE POWER SUPPLY. THE CUSTOMER PERFORMED QC, WHICH PASSED PER THE CUSTOMER'S SPECIFICATIONS. THE OLD POWER SUPPLY IS NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171181 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1