FDA Adverse Event Summary report: N

PLAVIX TEST

MDR report key: 1892877 · Received November 2, 2010

Report

Report Number
MW5018005
Date Received
November 2, 2010
Manufacturer
ACCUMETRICS
Product Code
JOZ
Report Source
Voluntary report
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

OUR LAB (B)(6) IS USING THE PLAVIX TEST MADE BY ACCUMETRICS. SEVERAL OF THE TECHS AND I HAVE NOTICED WHEN TAKING THE TESTS CARTRIDGES OUT OF THE MACHINE, BLOOD HAS BEEN LEAKING OUT OF VENT HOLES. THIS IS SUPPOSED TO BE A CLOSED SYSTEM. WE DO USE (B)(6) PRECAUTIONS WEARING GLOVES AND (B)(6). BLOOD IS LEAKING INSIDE THE MACHINE. WE CALLED THE COMPANY AND ASKED HOW WE COULD CLEAN MACHINE. WE WERE TOLD TO USE A CLEANING DEVICE. THE CLEANING DEVICE APPEARS ONLY TO BE (B)(6) TAPE WHICH DOES NOT THOROUGHLY CLEAN BLOOD OFF THE INSIDE INSTRUMENT. THE SYSTEM IS NOT ABLE TO BE CLEANED WITH A PROPER DISINFECT THAT WOULD KILL INFECTIOUS DISEASES. I HAVE CONCERNS THAT THIS SYSTEM IS EXPOSING ME, AND THE OTHER TECHS TO HIV OR OTHER DISEASES FROM BLOOD LEAKING OUT OF THESE DEVICES. I HAD THOUGHT THAT THIS WAS A CONCERN AT OUR HOSPITAL ONLY, HOWEVER, WHEN I WENT TO A CONFERENCE, EVERY TECH I TALKED TO SAID, THE BLOOD HAS LEAKED INTO THEIR MACHINE AS WELL. THEY COULD NOT CLEAN IT EITHER. THIS SEEMS TO BE A HEALTH HAZARD. WE WOULD APPRECIATE IT IF YOU COULD LOOK INTO THIS MATTER. I WISH TO REMAIN ANONYMOUS BECAUSE I HAVE CONCERNS THAT MY JOB MIGHT BE AT STAKE TO MAKE A FUSS OF THIS AT WORK.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 PLAVIX TEST NONE JOZ ACCUMETRICS

Patients

Seq Age Sex Outcome Treatment
1 *