BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3761194 · Received April 21, 2014

    Report

    Report Number
    1823260-2014-02873
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 29, 2014
    Report Date
    May 5, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC ROOT CAUSE OF THE POWER BOX FAILURE COULD NOT BE DETERMINED. PICTURES OF THE AFFECTED POWER BOX WERE PROVIDED AND IT CAN BE SEEN THAT PART OF THE PLANAR WINDING WAS MELTED. WITH A HIGH PROBABILITY, THIS CAUSED THE SMOKE COMING FROM THE INSTRUMENT. THERE WAS NO IMMINENT DANGER OF FIRE RELATED TO THIS POWER BOX FAILURE. ALL PARTS AND PLASTICS OF THE POWER BOX ARE UL RATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS SMOKE COMING FROM THE ANALYZER. THE ANALYZER WAS SHUT DOWN AND THE LABORATORY WAS EVACUATED. THE LABORATORY WAS FULL OF SMOKE AND A "BOTHERSOME FUME." THE FIRE DEPARTMENT ARRIVED AND THE LABORATORY PERSONNEL DID NOT GO BACK INSIDE THE LABORATORY UNTIL THE FIRE DEPARTMENT GAVE THE CLEAR. A FEMALE PHLEBOTOMIST IN THE LABORATORY LATER COMPLAINED OF A HEADACHE AS A RESULT OF SMOKE INHALATION. THE OFFICE NURSE GAVE THIS PERSON AN OVER THE COUNTER PAIN RELIEVER AS TREATMENT. THE PAIN RELIEVER RESOLVED THE HEADACHE AND THERE WAS NO FURTHER INCIDENT. IT WAS ASKED, BUT NO FURTHER INFORMATION COULD BE PROVIDED ABOUT THE PHLEBOTOMIST. NO OTHER HARM WAS EXPERIENCED BY THE LABORATORY PERSONNEL. THE FIELD SERVICE REPRESENTATIVE DETERMINED THAT THE POWER SUPPLY FAN FAILED, CAUSING THE POWER SUPPLY TO OVER HEAT. HE REPLACED THE POWER SUPPLY, WIRE HARNESS, AND POWER CONTROLLER PCB. HE BOOTED UP THE INSTRUMENT AND PERFORMED VOLTAGE MEASUREMENTS. HE RAN ALL AUTO MAINTENANCE FUNCTIONS SUCCESSFULLY. HE COMPLETED ISE CALIBRATIONS. THE OPERATOR RAN CALIBRATION AND QUALITY CONTROLS WITH ALL ASSAYS RECOVERING WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241173 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1