BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROBECHEK PATHVYSION HER-2/NEU NORMAL CONTROL

    MDR report key: 1497200 · Received September 1, 2009

    Report

    Report Number
    3005248192-2009-00003
    Event Type
    Malfunction
    Date Received
    September 1, 2009
    Date of Event
    August 4, 2009
    Report Date
    August 31, 2009
    Manufacturer
    ABBOTT MOLECULAR, INC.
    Product Code
    KIR
    PMA / PMN Number
    980024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT MOLECULAR AT THIS TIME BELIEVES THAT THIS INCIDENT IS A PACKAGING ERROR - I.E., THE CUSTOMER REPORTED THAT NO PACKAGING MATERIAL WAS USED TO WRAP THE BOX OF THE PROBECHEK SLIDES FOR THE PATHVYSION HER-2/NEU ASSAY. THE REVIEW OF THE OPERATING PROCEDURES FOR THE PACKAGING OF THE SLIDES WAS COMPLETED AND DETERMINED THAT ONLY COLD STORAGE BOXES OF SLIDES ARE CUSHIONED WRAPPED, BUT NOT FOR AMBIENT SHIPMENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT PROBECHEK PATHVYSION CONTROL SLIDES THAT WERE SHIPPED WERE BROKEN UPON ARRIVAL. THE PLASTIC CASE HOUSING THE PROBECHEK PATHVYSION CONTROL SLIDES HAD POPPED OPEN. THE CUSTOMER STATED TWO PROBLEMS WITH THE BOX'S CONTENTS: HEAVY REAGENTS WERE ON TOP OF THE PROBECHEK SLIDES, NO CUSHION WRAP WAS USED AROUND THE SLIDES DURING SHIPMENT. THE SLIDES WERE BROKEN. CUSTOMER STATED THAT A PERSON COULD HAVE CUT THEMSELVES DUE TO THE GLASS SHARDS. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROBECHEK PATHVYSION HER-2/NEU NORMAL CONTROL MICROSCOPIC SLIDES USED IN FISH TESTING KIR ABBOTT MOLECULAR, INC. TBD

    Patients

    Seq Age Sex Outcome Treatment
    1