BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS TAQSCREEN MPX TEST, VERSION 2.0

    MDR report key: 6547933 · Received May 3, 2017

    Report

    Report Number
    6547933
    Event Type
    Malfunction
    Date Received
    May 3, 2017
    Date of Event
    March 31, 2017
    Report Date
    April 26, 2017
    Manufacturer
    ROCHE MOLECULAR SYSTEMS, INC.
    Product Code
    MZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FALSE POSITIVE RATES USING THE ROCHE MOLECULAR SYSTEMS, INC COBAS TAQSCREEN MPX TEST, VERSION 2.0 EXCEEDED WHAT IS PUBLISHED IN THE PACKAGE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321582 COBAS TAQSCREEN MPX TEST, VERSION 2.0 COBAS TAQSCREEN MPX TEST, VERSION 2.0 MZP ROCHE MOLECULAR SYSTEMS, INC. X06559
    321583 COBAS TAQSCREEN MPX TEST, VERSION 2.0 COBAS TAQSCREEN MPX TEST, VERSION 2.0 MZP ROCHE MOLECULAR SYSTEMS, INC. X07609
    321584 COBAS TAQSCREEN MPX TEST, VERSION 2.0 COBAS TAQSCREEN MPX TEST, VERSION 2.0 MZP ROCHE MOLECULAR SYSTEMS, INC. X08493
    321585 COBAS TAQSCREEN MPX TEST, VERSION 2.0 COBAS TAQSCREEN MPX TEST, VERSION 2.0 MZP ROCHE MOLECULAR SYSTEMS, INC. X12815

    Patients

    Seq Age Sex Outcome Treatment
    1