BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5161157

    MDR report key: 5161157 · Received October 20, 2015

    Report

    Report Number
    5161157
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    May 2, 2015
    Report Date
    September 30, 2015
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ANALYZER BASE NOT WORKING. UNABLE TO PERFORM BASO WORM WITH ACCURATE RESULTS. MANUFACTURER RESPONSE FOR ANALYZER, (BRAND NOT PROVIDED) (PER SITE REPORTER): REPAIRED AND IT BECAME FULLY OPERATIONAL.

    Patients

    Seq Age Sex Outcome Treatment
    1