BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNAPURE LC SYSTEM

    MDR report key: 971574 · Received December 28, 2007

    Report

    Report Number
    1823260-2007-11156
    Event Type
    Malfunction
    Date Received
    December 28, 2007
    Date of Event
    March 5, 2007
    Report Date
    December 28, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LNJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING CROSS CONTAMINATION WHEN USING THE MAGNAPURE LC SYS. NO SPECIFIC DATA PROVIDED. THE INVESTIGATIONAL UNIT WAS NOT ABLE TO IDENTIFY THE ROOT CAUSE TO THIS PROBLEM. IT WAS NOTED, THE CUSTOMER IS USING NON SPECIFIED SAMPLE MATERIAL, THE CUSTOMER HAS REPORTED REAGENT SPLATTERING, AND THE CUSTOMER DOES NOT USE UNG TO ELIMINATE CONTAMINATIONS BY PCR PRODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNAPURE LC SYSTEM NUCLEIC ACID ISOLATION SYSTEM - LNJ ROCHE DIAGNOSTICS MAGNA PURE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR