BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 2133410 · Received June 20, 2011

    Report

    Report Number
    1823260-2011-03331
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE ROOT CAUSE WAS INCORRECT HANDLING BY THE CUSTOMER. THE CUSTOMER DID NOT FOLLOW THE PROCEDURE IN PRODUCT LABELING FOR REPLACEMENT OF THE FUSE. THE FUSE WAS CHANGED WITHOUT SWITCHING OFF THE INSTRUMENT'S MAIN POWER SWITCH. NO ONE WAS INJURED OR AFFECTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER STATED THEY HEARD A "POP", SMELLED A "HOT SMELL" AND DETERMINED THAT A FUSE HAD BLOWN AND THE FUSE HOLDER APPEARED TO HAVE MELTED OR FUSED TO THE INSTRUMENT. THE USER SAID "THE FUSE HOLDER AREA HAD SOME BLACK RESIDUE AS IF IT WAS CHARRED". NO PATIENTS WERE INVOLVED IN THE EVENT. NO INSTRUMENT OPERATORS OR LABORATORY PERSONNEL WERE INJURED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE USER WAS APPARENTLY REMOVING THE FUSE WITH THE POWER STILL ON. IT SPARKED AND MELTED THE FUSE HOLDER. HE REPLACED THE FUSE HOLDER, CAP AND FUSE. TO VERIFY THE ANALYZER OPERATION, HE SUCCESSFUL PERFORMED INITIALIZATION.

    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