BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CGH NORMAL MALE METAPHASE SLIDES 2 X 5 SLIDES

    MDR report key: 1675910 · Received April 23, 2010

    Report

    Report Number
    3005248192-2010-00001
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    April 12, 2010
    Report Date
    April 12, 2010
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    KEW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR IS INVESTIGATING THIS COMPLAINT IN (B)(4). MEDICAL DEVICE REPORT (MDR) 3005248192-2009-00003 WAS SENT TO THE FDA ON (B)(4), 2009 FOR A SIMILAR ISSUE OF BROKEN SLIDES FROM PATHVYSION PROBECHEK SLIDES.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ONE SLIDE BOX OF THE CGH NORMAL MALE METAPHASE SLIDES 2 X 5 SLIDES (LIST NUMBER 06J96-01) HAD ARRIVED WITH THE LID OPEN AND THE SLIDES WERE OUTSIDE OF THE BOX. ONE SLIDE WAS BROKEN. THE CUSTOMER TOOK CARE WHEN TAKING OUT THE SLIDES TO AVOID BEING INJURED. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CGH NORMAL MALE METAPHASE SLIDES 2 X 5 SLIDES MICROSCOPIC SLIDES USED IN FISH TESTING KEW ABBOTT MOLECULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1