BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY MONONUCLEOSIS RAPID TEST CASSETTE

    MDR report key: 9347166 · Received November 20, 2019

    Report

    Report Number
    9347166
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    October 7, 2019
    Report Date
    October 11, 2019
    Manufacturer
    CLARITY DIAGNOSTICS LLC
    Product Code
    KTN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN WAS USING A MONONUCLEOSIS SET TEST KIT. THE PIPETTE THAT COMES WITH KIT WOULD NOT PULL BLOOD FROM FINGERTIP INTO THE PIPETTE FOR TEST TO BE RAN. MULTIPLE PIPETTES WITH SAME PROBLEM (15 PER BOX). MANUFACTURER RESPONSE FOR MONOTEST KIT, CLARITY MONONUCLEOSIS RAPID TEST CASSETTE (PER SITE REPORTER). CLARITY DIAGNOSTICS CUSTOMER SERVICE NOTIFIED OF EQUIPMENT FAILURE. REPRESENTATIVE FROM CLARITY DIAGNOSTICS ARRANGED FOR 1 BOX OF DTG-MONO TO BE MAILED BY (B)(6) GROUND AS REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144393 CLARITY MONONUCLEOSIS RAPID TEST CASSETTE SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS KTN CLARITY DIAGNOSTICS LLC DTG-MONO 228F11

    Patients

    Seq Age Sex Outcome Treatment
    1 5840 DA