MalfunctionPRJ

AMASSE BLOOD TEST

Received May 23, 2023 · Event occurred Apr 28, 2023

Report MW5117791 · MDR key 16993998

Device

Generic name

Capillary Blood Collection Device For Alternative Site Collection

Manufacturer

Opans, Llc.

Product problems

Output Problem

Patient

31 YR · Female

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

I HAD THE STICK BLOOD TEST DONE AND IT SHOWED AS POSITIVE WHEN IN FACT I HAVE NOT USED, SO STATING THESE DEVICES ARE FAULTY AND NEED TOOK OF THE MARKET. MY OPINION JUST STAY USING A REG BLOOD DRAWN TEST AT HOSPITAL, IT'S MORE ACCURATE. AND BECAUSE THIS HAPPENED TO ME, IT CAUSED AN ISSUE WITH CPS (CHILD PROTECTIVE SERVICES) AND SO FOR THAT I DON'T GET TO SEE MY CHILD NOW. PLEASE HELP ME.