BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FETALSCREEN II

    MDR report key: 3603229 · Received January 21, 2014

    Report

    Report Number
    MW5034112
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    January 18, 2014
    Report Date
    January 20, 2014
    Product Code
    MWN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO PERFORM A FETAL SCREEN ON TWO PATIENTS, WITH THE FETALSCREEN II KIT LOT NUMBER V141993 EXPIRATION DATE 02/04/2014 THE KIT FAILED TO PRODUCE A POSITIVE CONTROL ACCEPTABLE RESULT, PATIENT TESTS WERE NOT REPORTED AND WERE SENT TO REFERENCE LAB FOR TESTING. CALLED ORTHO DIAGNOSTICS AND WAS TOLD BY TROUBLESHOOTING TECHNICIAN TO WASH THE CELLS BY HAND AND TO INCREASE CENTRIFUGE TIME TO CORRECT THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49683 FETALSCREEN II NONE MWN V141993

    Patients

    Seq Age Sex Outcome Treatment
    1