BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM

    MDR report key: 6100341 · Received November 14, 2016

    Report

    Report Number
    2023446-2016-00404
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 19, 2016
    Report Date
    October 19, 2016
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 SAMPLE SYRINGE PUMP ASSEMBLY WAS DEFECTIVE. THE FSE REPLACED THE SYRINGE PUMP TO RESOLVE THE REPORTED ISSUES. THE REPAIRS WERE VERIFIED PER ESTABLISHED SERVICE PROCEDURES. BEC INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT CB CONTROL WAS FAILING FOR BLOOD (FALSE POSITIVE) AND ALSO CA CONTROL WAS FAILING FOR PROTEIN (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
    752037 ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM AUTOMATED URINALYSIS SYSTEM KQO IRIS INTERNATIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1