MalfunctionKTN
CLARITY MONO TEST
Received Nov 20, 2019 · Event occurred Oct 7, 2019
Report 9347201 · MDR key 9347201
Device
Generic name
Mono Rapid Test
Manufacturer
Clarity Diagnostics LlcCatalog number
DTG-MONO
Lot number
228F11
Product problems
- Suction Failure
Patient
730 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
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.