BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3409673 · Received October 15, 2013

    Report

    Report Number
    1823260-2013-06292
    Event Type
    Malfunction
    Date Received
    October 15, 2013
    Date of Event
    September 17, 2013
    Report Date
    October 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT WHEN RECONNECTING THE ABSORBANCE HALOGEN LAMP A SMALL SPARK MAY BE GENERATED. THIS IS NOT A MALFUNCTION AND THE ENERGY OF THE SYSTEM DURING THIS PROCESS IS NOT ENOUGH TO HARM PERSONS OR DAMAGE THE INSTRUMENT. THIS INFORMATION IS PRESENT IN THE OPERATOR'S MANUAL.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED WHEN THEY REPLACED THE ABSORBANCE LAMP ON THE INSTRUMENT, SPARKS WERE OBSERVED WHEN THE LAMP WAS PUT ON. THE CUSTOMER THEN INDICATED THAT THEY SHUT THE SYSTEM DOWN, TOOK THE LAMP OFF, AND REPLACED IT WITH ANOTHER LAMP. SPARKS WERE NOT OBSERVED WITH THE SECOND LAMP. THE CUSTOMER INDICATED THERE WAS NO EVIDENCE OF FIRE OR SMOKE, JUST SPARKS WHEN THE LAMP WAS PUT ON. THERE WAS NO OPERATOR INJURY AND NO ONE WAS HARMED. THE LAMP WAS BEING REPLACED AS IT WAS DUE TO BE CHANGED. THE CUSTOMER DID NOT HAVE THE LOT NUMBER OF THE LAMP IN QUESTION. THE CUSTOMER DID NOT RETAIN THE LAMP IN QUESTION. IT WAS UNABLE TO BE DETERMINED IF THE CUSTOMER HAD FOLLOWED THE PROPER PROCEDURE FOR CHANGING THE LAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527984 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1