BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNAPURE LC

    MDR report key: 714340 · Received April 12, 2006

    Report

    Report Number
    714340
    Event Type
    Malfunction
    Date Received
    April 12, 2006
    Date of Event
    March 20, 2006
    Report Date
    April 12, 2006
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    LNJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ROCHE MAGNAPURE IS AN AUTOMATED SYSTEM TO EXTRACT PURIFIED DNA FROM PATIENT BLOOD SAMPLES. THE DNA IS THEN TESTED FOR GENETIC DISORDERS AND IS ALSO USED TO DETERMINE THE EFFICACY OF BONE MARROW TRANSPLANTS. IT WAS DISCOVERED THAT PATIENT SAMPLES WERE BEING CO-MINGLED DURING THE EXTRACTION PROCESS. THIS RESULTED IN MIXED DNA SAMPLES AND COULD HAVE YIELDED FALSE POSITIVE RESULTS. THE CONTAMINATION ISSUE SEEMS TO ONLY OCCUR WHEN USING THE "LARGE VOLUME" PROTOCOL (1.0 ML). THE LAB HAS DISCONTINUED THE LARGE VOLUME PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNAPURE LC DNA EXTRACTOR LNJ ROCHE DIAGNOSTICS CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *