BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICHEM VELOCITY

    MDR report key: 3748665 · Received November 22, 2013

    Report

    Report Number
    2023446-2013-00020
    Event Type
    Malfunction
    Date Received
    November 22, 2013
    Date of Event
    April 16, 2013
    Report Date
    November 22, 2013
    Manufacturer
    IRIS INTERNATIONAL
    Product Code
    JJW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED THE BAR CODE READER, PERFORMED AN ALIGNMENT, COMPLETED PERFORMANCE VERIFICATION CHECKLIST, RAN CONTROLS WHICH ALL PASSED, AND DISCUSSED SYSTEM PERFORMANCE WITH THE OPERATOR. CUSTOMER WAS ABLE TO RUN SPECIMENS WITHOUT ANY ISSUES. SYSTEM WAS OPERATIONAL.

    Description of Event or Problem · 1

    THE SAME BARCODE WAS READ INCORRECTLY FOR TWO PATIENTS ON TWO SEPARATE DATES DUE TO A MALFUNCTION. NO INJURY, TREATMENT OR CHANGE IN PATIENT MANAGEMENT WAS REPORTED BY THE CUSTOMER. THE ERROR WAS DETECTED PRIOR TO RELEASE OUTSIDE OF THE LAB. INFORMATION PERTAINING TO PATIENTS WAS NOT MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610228 ICHEM VELOCITY ICHEM VELOCITY JJW IRIS INTERNATIONAL 700-7177-001

    Patients

    Seq Age Sex Outcome Treatment
    1