BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY

    MDR report key: 4920153 · Received July 16, 2015

    Report

    Report Number
    2023446-2015-00201
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 16, 2015
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    KQO
    PMA / PMN Number
    K101852
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IRIS FIELD SERVICE ENGINEER WAS SENT TO THE CUSTOMER LOCATION AND CONFIRMED THE CONTROL FAILURES. THE FSE OBSERVED AIR IN THE LINE FROM THE COLOR, CLARITY, AND SPECIFIC GRAVITY MODULE (CGM) TO THE PROBE. THE FSE ALSO DISCOVERED A HOLE IN THE TUBING AT THE CGM FITTING. THE FSE REPLACED THE TUBING AND VERIFIED THE INSTRUMENT ALIGNMENTS. THE FSE RERAN CONTROLS AND THE CONTROLS PASSED. THE SYSTEM WAS OPERATIONAL. BEC INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER STATED THEY ARE FAILING MULTIPLE QUALITY CONTROLS FOR CONTROL LEVEL CA AND CONTROL LEVEL CB. THE CUSTOMER IS GETTING FALSE NEGATIVE CONTROLS FOR BILIRUBIN, GLUCOSE, UROBILINOGEN, AND KETONES. THE CUSTOMER ATTEMPTED TO TROUBLESHOOT BY USING FRESH CONTROLS OF THE SAME LOT. THE CUSTOMER IS USING CONTROL LOT #: 085-15. THE CUSTOMER WAS STILL GETTING CONTROL FAILURES AFTER USING FRESH CONTROLS. THE CUSTOMER ALSO RAN REFLECTANCE AND INDICATED THE REFLECTANCE PASSED. THERE WERE NO ERRONEOUS RESULTS GENERATED OR REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464334 ICHEM VELOCITY AUTOMATED URINE CHEMISTRY ANALYZER KQO IRIS INTERNATIONAL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1