BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRIS

    MDR report key: 1311143 · Received February 9, 2009

    Report

    Report Number
    1311143
    Event Type
    Malfunction
    Date Received
    February 9, 2009
    Date of Event
    January 3, 2009
    Report Date
    February 3, 2009
    Manufacturer
    IRIS DIAGNOSTICS DIVISION
    Product Code
    JJW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    URINALYSIS WAS COMPLETED AN SPERM WAS FOUND IN THE URINE ON ANALYSIS. IT WAS LATER BELIEVED THAT A PREVIOUS SPECIMEN HAD SPERM THAT HAD CARRYOVERED TO THE NEXT TWO SPECIMENS. UPON CONFERRING WITH THE MANUFACTURER, IT WAS DETERMINED THAT THE MACHINE HAS HAD IN ISSUE WITH SPERM CARRYOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IRIS IQ SERIES ANALYZER JJW IRIS DIAGNOSTICS DIVISION IQ 200 SPRINT ANAL

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR