BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEMVELOCITY URINE CHEMISTRY SYSTEM

    MDR report key: 6413119 · Received March 17, 2017

    Report

    Report Number
    6413119
    Event Type
    Malfunction
    Date Received
    March 17, 2017
    Date of Event
    February 8, 2017
    Report Date
    March 7, 2017
    Manufacturer
    IRIS INTERNATIONAL, INC.
    Product Code
    CDM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STAFF NOTICED SEVERAL PATIENTS WERE OBTAINING POSITIVE URINE GLUCOSE RESULTS OF 50 ON THE VELOCITY ANALYZER. SEVERAL OF THESE PATIENTS HAD TESTS REPEATED ON THE BACK-UP ANALYZER AND THEN OBTAINED A NEGATIVE VALUE. AT THIS POINT, THE INSTRUMENT WAS TAKEN OUT OF SERVICE AND THE BACK-UP ANALYZER WAS PUT INTO USE. SERVICE ARRIVED TWO DAYS LATER AND WE THOUGHT THE ISSUE WAS RESOLVED, HOWEVER THE POSITIVE GLUCOSES RETURNED THAT EVENING AND INSTRUMENT WAS AGAIN TAKEN OUT OF SERVICE. SERVICE ARRIVED AGAIN AND PROBLEM WAS RESOLVED FIVE DAYS AFTER THE INITIAL INCIDENT. IT WAS DETERMINED THAT THE SAMPLE PROBE WASN'T BEING COMPLETELY WASHED OF PATIENT SAMPLES IN BETWEEN ASPIRATIONS AND RESULTS WERE CARRYING OVER FROM PREVIOUS SAMPLES. MANUFACTURER RESPONSE: FOR IRIS VELOCITY URINE CHEMISTRY ANALYZER, BECKMAN IRIS (PER SITE REPORTER)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195713 ICHEMVELOCITY URINE CHEMISTRY SYSTEM DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) CDM IRIS INTERNATIONAL, INC. VELOCITY

    Patients

    Seq Age Sex Outcome Treatment
    1