BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 3893481 · Received June 25, 2014

    Report

    Report Number
    1823260-2014-04644
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 1, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REPRESENTATIVE REPLACED THE KIT VOLTAGE SELECTOR (PCB) PRINTED CIRCUIT BOARD. AFTER REPLACEMENT, ALL WAS WORKING FINE WITH NO ERROR CODES.

    Description of Event or Problem · 1

    THE BIOMED ENGINEER (BME) REPORTED A FUSE WAS BLOWN AND THE FUSE HOLDER WAS CRUMBLED AS IF IT HAD BEEN BURNED. THE ANALYZER HAD BEEN POWERED OFF BY THE OPERATOR AFTER HAVING TROUBLE REMOVING A SAMPLE RACK AND RECEIVING AN ANALYZER ALARM. THE BME REMOVED THE LEFT SIDE PANEL TO CHECK THE FUSES. HE FOUND THE F2 FUSE HOLDER COMPLETELY CRUMBLED WHEN HE TRIED TO TAKE IT OUT OF THE ANALYZER. HE STATED THE FUSE ITSELF WAS A LIGHT BROWN COLOR LIKE IT HAD BEEN BURNED. HE STATED THERE WERE NO ODORS, SMOKE, FUMES OR MELTING THAT HE OBSERVED. NO PATIENTS WERE INVOLVED. THERE WAS NO ADVERSE EVENT. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ANALYZER FOR A CAUSE OF THE FUSE FAILURE COULD NOT FIND A CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371729 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1