BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM

    MDR report key: 6017908 · Received October 11, 2016

    Report

    Report Number
    2023446-2016-00384
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 19, 2016
    Report Date
    September 19, 2016
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE AND OBSERVED THAT THE COLOR GRAVITY MODULE (CGM) REQUIRED REPLACEMENT. THE FSE ALSO FOUND THAT THE SYRINGE PUMP ASSEMBLY WAS ALSO MALFUNCTIONING AND NOT ALLOWING FOR THE COMPLETION OF THE CGM CALIBRATION. HE REPLACED THE CGM ASSEMBLY, IT'S RESPECTIVE TUBING, AND THE SYRINGE PUMP ASSEMBLY AND WAS ABLE TO RUN THE INSTRUMENT WITHOUT FURTHER ISSUES. THE REPAIRS WERE VERIFIED PER ESTABLISHED SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM WAS LEAKING FROM THE COLOR GRAVITY MODULE (CGM). THE LEAK CONSISTED OF ONLY A FEW DROPS ONTO THE STRIP PROVIDER MODULE (SPM). THE CUSTOMER WAS WEARING PERSONAL PROTECTION EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES AT THE TIME OF DISCOVERY. MEDICAL ATTENTION WAS NOT SOUGHT, THERE WAS NO DIRECT EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. ERRONEOUS PATIENT RESULTS WERE NOT REPORTED OUT AND THERE WAS NO CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669539 ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM AUTOMATED URINALYSIS SYSTEM KQO IRIS INTERNATIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1