BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LABORATORY CORPORATION DNA ANALYSIS MACHINE

    MDR report key: 479348 · Received August 20, 2003

    Report

    Report Number
    MW1029331
    Event Type
    Malfunction
    Date Received
    August 20, 2003
    Date of Event
    April 8, 2003
    Report Date
    August 15, 2003
    Manufacturer
    LABORATORY CORP OF AMERICA
    Product Code
    LNJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER TOOK TEST WITH A LAB, REPORTER BELIEVES THE MACHINES DID NOT TEST THE TEST PROPERLY. REPORTER HAS REASON TO BELIEVE THE LAB COPY RESULTS WERE FROM ANOTHER DNA LAB. THE TEST WAS DONE WITH REPORTER'S SIGNIFICANT OTHER. PLEASE CHECK SYSTEMS FOR ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LABORATORY CORPORATION DNA ANALYSIS MACHINE DNA MACHINE LNJ LABORATORY CORP OF AMERICA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other