BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH PURE SYSTEM VIRAL NUCLEIC ACID KIT

    MDR report key: 1723076 · Received June 8, 2010

    Report

    Report Number
    MW5016285
    Event Type
    Malfunction
    Date Received
    June 8, 2010
    Date of Event
    May 24, 2010
    Report Date
    June 8, 2010
    Manufacturer
    ROCHE MOLECULAR SYSTEMS
    Product Code
    MZP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FROM (B) (6) 2010 TO (B) (6) 2010: CAPS ON THE WELLS OF THE LYSIS RACK DO NOT CLOSE TIGHTLY CAUSING CROSS-CONTAMINATION OF THE SPECIMEN AND ALSO CONTAMINATION OF CENTRIFUGE. DATES OF USE: #1 - (B) (6) 2010 - (B) (6) 2010; #2 - (B) (6) 2010 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: #1 - (B) (6) VIRAL LOAD ASSAY; #2 (B) (6) VIRAL LOAD ASSAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH PURE SYSTEM VIRAL NUCLEIC ACID KIT NONE MZP ROCHE MOLECULAR SYSTEMS 15722000
    2 HIGH PURE SYSTEM VIRAL NUCLEIC ACID KIT NONE MZP ROCHE MOLECULAR SYSTEMS 15518100

    Patients

    Seq Age Sex Outcome Treatment
    1