BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY

    MDR report key: 4102690 · Received August 28, 2014

    Report

    Report Number
    2023446-2014-00141
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 4, 2013
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE CHEM VELOCITY URINE CHEMISTRY ANALYZER SHOWED FALSE NEGATIVE FOR BLOOD AND LEUKOCYTE ESTERASE ON 3 PT SAMPLES, WHEREAS THE IQ200 URINE MICROSCOPY ANALYZER AND MANUAL MICROSCOPIC METHODS CONFIRMED THAT THOSE SAMPLES HAD THE PRESENCE OF RBCS AND WBCS. NO CHANGE TO PT MANAGEMENT REPORTED. FSE FOUND PROBLEM WITH STRIPS NOT BEING DOSED PROPERLY. FSE CHECKED ALL TUBING CONNECTIONS FROM SAMPLE PROBE TO DFS. DURING PRIMING OF SYSTEM, FSE NOTICED THAT PISTON ON THE SYRINGE STOPPED MOVING, REMOVED SYRINGE AND CHECK FOR DAMAGE SYRINGE PISTON CONES APART, REPLACED SYRINGE ASSEMBLY AND TIGHTEN PROPERLY. FSE PRIMED SYSTEM, RUN QC ALL IN SPECIFICATION. SYSTEM WAS OPERATIONAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSTRUMENT WAS NOT ASPIRATING SAMPLES AND RESULT NOT MATCHING WITH MICROSCOPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526171 ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER KQO IRIS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1