inforMED
MalfunctionKTN

CLARITY MONONUCLEOSIS RAPID TEST CASSETTE

Received Nov 20, 2019 · Event occurred Oct 7, 2019

Report 9347166 · MDR key 9347166

Device

Generic name

System, Test, Infectious Mononucleosis

Model number

DTG-MONO

Catalog number

DTG-MONO

Lot number

228F11

Product problems

  • Suction Failure

Patient

5840 DA

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

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.