BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBECHEK MULTIVYSION CONTROL SLIDES

    MDR report key: 3459855 · Received November 12, 2013

    Report

    Report Number
    3005248192-2013-00015
    Event Type
    Malfunction
    Date Received
    November 12, 2013
    Date of Event
    October 11, 2013
    Report Date
    October 11, 2013
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    LDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION AT ABBOTT MOLECULAR IS IN PROGRESS FOR MDR 300524-2013-00015. AN MDR FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE COMPLAINT INVESTIGATION CONCLUDES. INVESTIGATED W/O DEVICE RETURNED.

    Description of Event or Problem · 1

    ABBOTT MOLECULAR, INC. RECEIVED A COMPLAINT FOR PROBECHEK MULTIVYSION CONTROL SLIDES (LIST 05J07-01) REPORTING ONE BROKEN SLIDE WHEN THE SLIDE BOX WAS FIRST OPENED. THERE WAS NO REPORT OF INJURY. IF THIS EVENT WERE TO RECUR, IT IS POSSIBLE THAT A USER COULD BE CUT BY A BROKEN SLIDE AND EXPOSED TO POTENTIALLY INFECTIOUS MATERIAL. THEREFORE, RECURRENCE OF THIS ISSUE COULD POTENTIALLY CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585327 PROBECHEK MULTIVYSION CONTROL SLIDES MICROSCOPIC CONTROL SLIDES LDT ABBOTT MOLECULAR, INC. 448842

    Patients

    Seq Age Sex Outcome Treatment
    1