BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RED BLOOD CELL DILUENT MTS DILUENT 2 PLUS

    MDR report key: 10843806 · Received November 13, 2020

    Report

    Report Number
    MW5097895
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    September 23, 2020
    Report Date
    November 12, 2020
    Manufacturer
    ORTHO CLINICAL DIAGNOSTICS, INC.
    Product Code
    KSG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE BOTTLES OF MTS DILUENT 2 AND MTS DILUENT 2 PLUS LOOK NEARLY IDENTICAL MAKING IT EASY TO INADVERTENTLY SELECT THE WRONG BOTTLE OF DILUENT. THIS HAS POTENTIAL TO CAUSE AN IMPORTANT MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305541 RED BLOOD CELL DILUENT MTS DILUENT 2 PLUS MEDIA, POTENTIATING FOR IN VITRO DIAGNOSTIC USE KSG ORTHO CLINICAL DIAGNOSTICS, INC. MDP191
    1305542 RED BLOOD CELL DILUENT MTS DILUENT 2 MEDIA, POTENTIATING FOR IN VITRO DIAGNOSTIC USE KSG ORTHO CLINICAL DIAGNOSTICS, INC. MD142

    Patients

    Seq Age Sex Outcome Treatment
    1 Other