BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSIL RINSE SOLUTION 4L

    MDR report key: 6050640 · Received October 24, 2016

    Report

    Report Number
    6050640
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    March 1, 2016
    Report Date
    October 7, 2016
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JJX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WE EXPERIENCED CONTAMINATION ISSUES WITH OUR COAG INSTRUMENT RINSE SOLUTION. MICROBIOLOGICAL CULTURES FROM UNOPENED RINSE SOLUTION GREW SEVERAL MICRO-ORGANISMS - GRAM POSITIVE BACILLI. NEW LOT OF REAGENT REQUESTED FROM MANUFACTURER; UNOPENED RINSE SOLUTION CULTURED AND GROWTH OF PSEUDOMONAS PRESENT. WHAT WE COULD TELL, IT IMPACTED ONLY ONE TEST - HOMOCYSTEINE. WITH HOMOCYSTEINE QC RUNNING ON THE LOW SIDE OF THE MEAN DURING THIS EVENT, RATHER THAN BOUNCING UP AND DOWN ABOVE/BELOW THE MEAN LIKE IT SHOULD, THIS INDICATES THAT THE TEST RESULTS REPORTED DURING THIS EVENT ALSO COULD BE FALSELY LOWER THAN ACTUAL. WE REPORTED THE EVENT TO THE MANUFACTURER SEVERAL TIMES. DUE TO OUR CONCERN FOR ACCURACY, A COUPLE OF MONTHS AFTER THE INITIAL EVENT, WE DISCONTINUED DOING THE TEST IN-HOUSE AND BEGAN SENDING OUT TO A REFERENCE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701094 HEMOSIL RINSE SOLUTION 4L SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) JJX INSTRUMENTATION LABORATORY CO. N0260824

    Patients

    Seq Age Sex Outcome Treatment
    1