BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS 24 PLACE CENTRIFUGE

    MDR report key: 1022660 · Received April 1, 2008

    Report

    Report Number
    1056600-2008-00105
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 10, 2008
    Report Date
    April 1, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    KSO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE WAS DETERMINED. THE CENTRIFUGE WAS OUT OF WARRANTY. THE CUSTOMER'S BIO MED TECH WAS INSTRUCTED TO CHECK THE GEL CARDHOLDERS FOR FREE MOVEMENT. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS INSTRUMENT SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MTS 24 PLACE CENTRIFUGE WAS NOT IN SPECIFICATION. THE USER DETECTED THE ISSUE AND RETESTED USING AN ALTERNATE CENTRIFUGE PREVENTING ERRONEOUS RESULTS FROM BEING REPORTED. INCORRECT CENTRIFUGATION SPEED OR TIME DURING TESTING, IF UNDETECTED, MAY LEAD TO ERRONEOUS TEST RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS 24 PLACE CENTRIFUGE CENTRIFUGE KSO MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1