BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTTR

    MDR report key: 1610365 · Received February 16, 2010

    Report

    Report Number
    MW5014796
    Event Type
    Malfunction
    Date Received
    February 16, 2010
    Report Date
    February 16, 2010
    Manufacturer
    HKS MEDICAL INFO SYSTEMS
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HLA SOFTWARE SYSTEM WITHOUT ANY DOCUMENTATION THAT PERFORMS HLA MATCH CALCULATIONS AND REPORTING. UNABLE TO ACQUIRE USER MANUALS. TRANSPLANT SOFTWARE CALLED OTTR THAT PERFORMS CALCULATIONS AND RELATIVE DETERMINATIONS ON PT DATA AND USES ALOGRITHMS TO DETERMINE PT TREATMENT PLANS. UNABLE TO ACQUIRE DOCUMENTATION AND ADEQUATE USER MANUALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTTR HLA SOFTWARE LNX HKS MEDICAL INFO SYSTEMS OTTR
    2 OTTR HLA TRANSPLANT SOFTWARE MMH HKS MED INFO SYSTEMS OTTR HLA

    Patients

    Seq Age Sex Outcome Treatment
    1