BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MTS INCUBATOR

    MDR report key: 905909 · Received August 31, 2007

    Report

    Report Number
    1056600-2007-00245
    Event Type
    Malfunction
    Date Received
    August 31, 2007
    Date of Event
    August 1, 2007
    Report Date
    August 31, 2007
    Manufacturer
    MICRO TYPING SYSTEMS, INC.
    Product Code
    JTQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED. ASSISTANCE PROVIDED TO THE CUSTOMER OVER THE PHONE HAS RESOLVED THE ISSUE. THIS CUSTOMER HAS NOT LOGGED ANY COMPLAINTS AGAINST THIS INSTRUMENT SINCE THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THAT, THE TEMPERATURE OF THE MTS INCUBATOR WAS OUT OF SPECIFICATION. INCORRECT INCUBATION TEMPERATURE CAN LEAD TO FALSE POSITIVE AND FALSE NEGATIVE TEST RESULTS, WHICH CAN LEAD TO TRANSFUSION OF INCOMPATIBLE BLOOD. ERRONEOUS TEST RESULTS WERE NOT REPORTED AS A RESULT OF THIS INCIDENT.

    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 YR