BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTPATH

    MDR report key: 686923 · Received March 13, 2006

    Report

    Report Number
    1058332-2006-00014
    Event Type
    Malfunction
    Date Received
    March 13, 2006
    Report Date
    March 9, 2006
    Manufacturer
    SCC SOFT COMPUTER
    Product Code
    LNX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THERE WAS A CASE IN THE DATABASE WHICH APPEARED CORRUPTED. THE PRINTED LABELS FOR THE CASE SHOWED THAT THE CASE SUA05-20259 HAD TWO MRN NUMBERS ASSIGNED, #0694179 AND #0440434. THE SPECIMENS FROM THE SECOND MRN ARE PRESENT WITH THE DEMOGRAPHIC OF THE FIRST MRN IN THE DATABASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTPATH LABORATORY INFORMATION SOFTWARE LNX SCC SOFT COMPUTER * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA