BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTILITE ANALYSER

    MDR report key: 4792538 · Received May 11, 2015

    Report

    Report Number
    9614373-2015-00001
    Event Type
    Malfunction
    Date Received
    May 11, 2015
    Date of Event
    April 10, 2015
    Report Date
    May 7, 2015
    Manufacturer
    THE BINDING SITE GROUP LTD.
    Product Code
    CEF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSER IS MANUFACTURED BY THERMO FISHER (B)(4), WHO ARE RESPONSIBLE FOR DESIGN AND PRODUCTION. THE ANALYSER IS BADGED FOR BINDING SITE, WHO ARE RESPONSIBLE FOR MARKETING AND AFTER-SALES SERVICE, INCLUDING VIGILANCE. THIS EVENT HAS ALREADY BEEN REPORTED BY BINDING SITE TO THE NAT'L COMPETENT AUTHORITY IN THE (B)(4) THE MHRA ((B)(4)). THERE IS CURRENTLY ONE OPTILITE ANALYSER IN THE US, BEING USED FOR EVALUATION PURPOSES ONLY, NOT FOR MEDICAL PURPOSES. COMMENTS ON THE CAUSE OF THE EVENT ARE PROVIDED IN B5. IN THE SHORT TERM, CURRENT USERS WILL BE WARNED BY A FIELD SAFETY NOTICE OF THE RISK OF THE COVER CLOSING WHEN NOT IN THE FULLY OPEN POSITION. IN THE LONGER TERM, THE ANALYSER NEEDS TO BE MODIFIED BY THE ORIGINAL MANUFACTURER (THERMO FISHER) TO EITHER HAVE A STRONGER GAS STRUT FITTED OR PROVIDED WITH SOME TYPE OF LOCKING MECHANISM FOR WHEN THE COVER IS IN THE OPEN POSITION.

    Description of Event or Problem · 1

    THE COVER ON THE OPTILITE ANALYSER WAS OPENED TO ACCESS THE INSIDE OF THE ANALYSER. THE TRAINED MEMBER OF BINDING SITE'S STAFF (APPLICATIONS SPECIALIST) THOUGHT THAT THE COVER WAS IN THE FULLY OPEN POSITION BUT WHILST HE WAS REMOVING REAGENTS, THE COVER FELL ON THE OPERATOR'S ARM CAUSING BRUISING. THE OPERATOR IS EXPERIENCED IN USING THE OPTILITE ANALYSER. THE EVENT OCCURED AT THE MANUFACTURER'S OWN PREMISES IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306008 OPTILITE ANALYSER CEF THE BINDING SITE GROUP LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1