BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS INCUBATOR

    MDR report key: 1060814 · Received June 12, 2008

    Report

    Report Number
    1056600-2008-00198
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 19, 2008
    Report Date
    June 12, 2008
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    JTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A POSSIBLE ROOT CAUSE WAS DETERMINED. THE CUSTOMER'S BIOMED TECH INADVERTENTLY KNOCKED THE POWER CORD OUT OF THE INCUBATOR CAUSING THE INCUBATOR POWER CORD OUT OF THE INCUBATOR CAUSING THE INCUBATOR POWER TO BE OFF. SINCE THE POWER WAS OFF, THE GEL CARD IN QUESTION WAS NOT INCUBATED AT THE CORRECT TEMPERATURE, RESULTING IN THE FALSE NEGATIVE RESULTS. REPAIRS WERE NOT REQUIRED SINCE INSTRUMENT MALFUNCTION DID NOT OCCUR. USER ERROR COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE CUSTOMER INDICATED IT IS NOW REQUIRED BY THEIR STAFF TO INSPECT THE POWER CORD AT THE BEGINNING OF EACH SHIFT. INCIDENT IS ISOLATED. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS INSTRUMENT SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY OBTAINED A FALSE ANTIBODY SCREEN RESULT WITH A PT'S SAMPLE ON THE MTS INCUBATOR. THE CUSTOMER PERFORMED INVESTIGATION AND INDICATED THAT THEIR BIOMED HAD ACCIDENTALLY KNOCKED THE POWER CORD OUT OF THE MTS INCUBATOR SHORTLY AFTER A GEL RACK HAD BEEN INSERTED. THE TECH FAILED TO NOTICE THE OUT OF RANGE INCUBATOR LIGHT (INCUBATOR POWER WAS OFF) WHEN THE INCIDENT OCCURRED. THE PT VISITED THE FACILITY 7 DAYS LATER FOR TRANSFUSION AND THE DISCREPANCY WAS NOTED UPON REPEAT TESTING FOR BLOOD WORK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MTS INCUBATOR MTS GEL CARD INCUBATOR JTQ MICRO TYPING SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1