BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 3466422 · Received November 13, 2013

    Report

    Report Number
    1823260-2013-06901
    Event Type
    Malfunction
    Date Received
    November 13, 2013
    Date of Event
    November 2, 2013
    Report Date
    November 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED AN ANALYZER MESSAGE RELATING TO THE ABSORBANCE PHOTOMETER LAMP (ABS). WHEN THE CUSTOMER TRIED TO REINITIALIZE THE LAMP, SHE NOTICED THE SOCKET THE LAMP PLUGS INTO HAD MELTED. THERE WAS NO SMOKE, FIRE OR FUMES. NO OPERATORS WERE INJURED. NO PATIENTS WERE INVOLVED. THERE WAS NO ADVERSE EVENT. THE CUSTOMER NOTED SHE HAD CHANGED THE ABS LAMP EARLIER IN THE DAY. THE FIELD SERVICE REPRESENTATIVE NOTED THE PHOTOMETER LAMP CONNECTOR WAS BURNT AND MELTED. HE DETERMINED THE ELECTRICAL CONNECTOR ON THE ABS LAMP WAS NOT SEATED IN ITS CONNECTOR AND CAUSED THE CONNECTION TO OVERHEAT AND MELT. HE REPLACED THE ABS LAMP AND PCB ABS MODULE. HE CONFIRMED OPERATION BY RUNNING START UP PROCEDURES AND ABS LAMP WATER BLANK. THE CUSTOMER RAN AND VERIFIED QC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587162 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1