BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 3972735 · Received August 1, 2014

    Report

    Report Number
    1823260-2014-05782
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 27, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION DETERMINED THE ANALYZER ALARMS INDICATED A LINE POWER FLUCTUATION WHICH CAUSES THERMAL STRESS ON THE FUSE HOLDER. IT WAS CONFIRMED THE SERVICE ACTION OF REPLACING THE POWER MODULE PCB RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THE "FUSE HOLDER WAS GONE". THERE WAS NOTHING LEFT BUT BLACK ASH AND A BLACK WIRE IN THE ANALYZER'S FUSE HOLE. THE REMAINS OF THE FUSE WERE DISCARDED. THE CUSTOMER STATED THE ANALYZER ALARMS WERE "OVERHEATING ERRORS" AND NOTED THE ANALYZER HAD BEEN PUSHED VERY CLOSE TO THE BACK WALL. THE CUSTOMER AGREED THIS WOULD IMPEDE VENTILATION OF THE ANALYZER.

    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 RECEIVED ANALYZER ALARMS AND REPLACED THE FUSE. WHEN THE ANALYZER WAS RESTARTED, THE CUSTOMER SAW SMOKE. IT APPEARED THAT THE FUSE HOLDER HAD MELTED AND HALF OF THE FUSE WAS STILL INSIDE THE ANALYZER. THE CUSTOMER VERIFIED THAT NO ONE WAS INJURED OR HARMED. NO PATIENTS WERE INVOLVED IN THE EVENT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS AN ELECTRONIC FAILURE OF THE FUSE PRINTED CIRCUIT BOARD (PCB) AND HE REPLACED THE PCB. HE SUCCESSFULLY POWERED ON THE ANALYZER AND PERFORMED INITIALIZATION SUCCESSFULLY. HE VERIFIED THE SYSTEM WAS PERFORMING TO SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450555 COBAS INTEGRA 800 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1