BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY MONO TEST

    MDR report key: 9347201 · Received November 20, 2019

    Report

    Report Number
    9347201
    Event Type
    Malfunction
    Date Received
    November 20, 2019
    Date of Event
    October 7, 2019
    Report Date
    October 18, 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

    NURSE USED PIPETTES IN ATTEMPT TO RUN MONOTEST. PIPETTE WOULD NOT PULL BLOOD IN PIPETTE FROM FINGER STICK. MONOTEST CANCELLED. 2 TESTS HAD SAME PROBLEM WITH DRAWING BLOOD INTO PIPETTE. MANUFACTURER RESPONSE FOR MONO RAPID TEST, (BRAND NOT PROVIDED) (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
    1145265 CLARITY MONO TEST MONO RAPID TEST KTN CLARITY DIAGNOSTICS LLC 228F11

    Patients

    Seq Age Sex Outcome Treatment
    1 730 DA