BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 800

    MDR report key: 2063419 · Received April 19, 2011

    Report

    Report Number
    1823260-2011-02108
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE IMPLICATED PART WAS NOT POSSIBLE BECAUSE THE PCB POWER MODULE HAD ALREADY BEEN DISPOSED. THE ROOT CAUSE OF THE ISSUE WAS MOST PROBABLY A DAMAGED FUSE HOLDER DUE TO PREVIOUS FUSE REPLACEMENT PERFORMED WITHOUT SWITCHING OFF THE ANALYZER POWER. REPLACEMENT OF THE FUSE IS DOCUMENTED IN LABELING (THE USER MANUAL). AFTER REPLACING THE FUSE HOLDER, THE INSTRUMENT APPEARED TO BE FUNCTIONING NORMALLY. THE MATERIAL USED IN THE POWER MODULE IS UL CERTIFIED AND HAS LOW FLAMMABILITY. NO PATIENTS WERE INVOLVED IN THE ISSUE. NO INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED AN INSTRUMENT ERROR DURING INITIALIZATION. SHE FOUND THE F3 FUSE INDICATION LIGHT WAS RED INDICATING THE FUSE NEEDED TO BE REPLACED. THE CUSTOMER WAS UNABLE TO CHANGE THE FUSE (THE TOP OF THE FUSE BROKE OFF WHEN SHE ATTEMPTED TO REPLACE IT). THE FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO ASSIST. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE FUSE HOLDER WAS DAMAGED AND THE PRINTED CIRCUIT BOARD SHOWED EVIDENCE OF OVERHEATING. HE REPLACED THE FUSE HOLDER AND BLOWN FUSE. HE VERIFED THE COOLING UNIT WAS TURNED ON AND DRAWING A NORMAL AMOUNT OF CURRENT. THE FIELD SERVICE REPRESENTATIVE COMPLETED ANALYZER INITIALIZATION AND PERFORMED QUALITY CONTROL. NO PATIENT SAMPLES WERE INVOLVED IN THIS EVENT AND NO OPERATORS WERE INJURED.

    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