BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 2140828 · Received June 27, 2011

    Report

    Report Number
    1823260-2011-03460
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 8, 2011
    Report Date
    October 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS UNABLE TO DETERMINE A ROOT CAUSE AS THE DEFECTIVE POWER SUPPLY WAS DISCARDED AND WAS NOT AVAILABLE FOR INVESTIGATION. FOR EXISTING POWER SUPPLIES, AN UPDATE WAS MADE TO THE CLEANING PROCEDURE IN THE HALF YEAR MAINTENANCE AND REPLACEMENT OF THE SPARE PART FAN ASSEMBLY POWER SUPPLY EVERY THREE YEARS. AN IMPROVEMENT TO THE EXISTING TYPE OF POWER SUPPLY WITH A NEW OVER TEMPERATURE SWITCH WAS FIRST INSTALLED IN (B)(6) 2010. ALSO, A NEW TYPE OF POWER SUPPLY WAS INTRODUCED. NO ONE WAS INJURED OR AFFECTED. NO ERRONEOUS TEST RESULTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVIDENCE OF FIRE. ALL PARTS AND PLASTICS ARE UL RATED ACCORDINGLY. SMOKE EMITTED FROM THE UNIT DUE TO A PLASTIC ISOLATOR WHICH MELTED. NO PATIENT RESULTS WERE AFFECTED AND NO LABORATORY PERSONNEL WERE INJURED.

    Description of Event or Problem · 1

    THE USER EXPERIENCED THE ANALYZER SMOKING. SHE STATED THERE WAS NO FIRE, BUT THERE WAS SO MUCH BLACK SMOKE THAT THE LABORATORY HAD TO BE EVACUATED. NO LABORATORY PERSONNEL WERE INJURED BY THE SMOKE. NO PATIENT SAMPLES WERE INVOLVED IN THE EVENT; THEREFORE NO PATIENTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A FAULTY POWER SUPPLY AND REPLACED IT. HE ALSO REPLACED THE PCB POWER MANAGER AND THE ASSOCIATED CABLES IN THE MAIN POWER SUPPLY. TO VERIFY THE ANALYZER OPERATION, HE VISUALLY INSPECTED THE ANALYZER AND PERFORMED DAILY MAINTENANCE. THE USER RAN QUALITY CONTROL WITH RESULTS WITHIN THEIR SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1