BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM

    MDR report key: 6090561 · Received November 9, 2016

    Report

    Report Number
    2023446-2016-00398
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 17, 2016
    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

    THE FIELD SERVICE ENGINEER (FSE) WAS AT THE CUSTOMER SITE AND OBSERVED BUBBLES IN THE TUBING AT THE PROBE. THE FSE REPLACED THE DOSAGE FLUIDIC SYSTEM (DFS) TO RESOLVE THE INSTRUMENT ISSUE. THE REPAIRS WERE VERIFIED PER ESTABLISHED SERVICE PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE CA CONTROL FOR BILIRUBIN WAS FAILING (FALSE NEGATIVE) ON THEIR ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM. THERE WERE NO REPORTS OF ERRONEOUS PATIENT RESULTS BEING GENERATED OR 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
    739629 ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM AUTOMATED URINALYSIS SYSTEM KQO IRIS INTERNATIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1