FDA Adverse Event Malfunction Summary report: N

PATENTED AMASSE DEVICE

MDR report key: 18486828 · Received January 9, 2024

Report

Report Number
MW5150091
Event Type
Malfunction
Date Received
January 9, 2024
Date of Event
December 12, 2023
Report Date
January 5, 2024
Manufacturer
OPANS LLC
Product Code
OQS
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
WV, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I AM AT A DRUG COURT AND PROBATION PROGRAM AND HAVE TO TAKE DRUG TESTING A FEW TIMES A WEEK. USUALLY BY URINE OR A MOUTH SWAB (MADE BY PHARMACHECK), I'VE NEVER HAD A PROBLEM WITH IT. WELL, AFTER THANKSGIVING, WE ALL AT DRUG COURT WERE GIVEN A DIFFERENT TYPE OF DRUG TEST; IT WAS THE AMASSE SELF-STICK BLOOD TEST MADE BY OPANS LLC. EVERYONE IN THE PROGRAM HAD FAILED THE TEST, AND IT JUST SEEMED STRANGE BECAUSE I, FOR ONE, I KNEW THAT I DIDN'T USE ANY ILLEGAL SUBSTANCES, AND PEOPLE WITH OVER TWO YEARS OF SOBER TIME CLAIM THEY DIDN'T USE ANY ILLICIT SUBSTANCES. ONE PERSON ALMOST QUIT GOING TO DRUG COURT AND THREW AWAY THEIR SOBRIETY. I WASN'T ALLOWED TO SEE MY TEST RESULTS FOR CONFIRMATION, BUT I DID GET A GLANCE AT THE PAPER TO SEE ITS NAME. SO I LOOKED IT UP AND LEARNED THAT IT IS NOT FDA-APPROVED AND SEEMS JUST A LITTLE BIT ILLEGAL TO USE IN A FEDERAL PROGRAM; I'M SURE THERE ARE SOME REGULATIONS. WELL, I'M HERE TO REPORT THE DEVICE AND PRAY IT IS TAKEN INTO SOME CONSIDERATION FOR AN INVESTIGATION BECAUSE IF MY DRUG COURT PROGRAM IS USING THIS DEVICE AND PROVEN TO BE INCORRECT, THEN THAT MEANS ALL ACROSS WV, OTHER PROBATION IS USING IT, AND INNOCENT PEOPLE FIGHTING FOR SOBRIETY ARE GOING TO JAIL, LOSING THEIR CHILDREN, OR GIVING UP AND ENDING UP GOING TOWARDS AN OVERDOSE. THAT'S ALL PRETTY MUCH. I PRAY FOR A RESPONSE, PLEASE, AND THANK YOU. REFER TO ADDITIONAL DOCUMENTS IN I2K.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1627592 PATENTED AMASSE DEVICE LABORATORY DEVELOPED TEST OQS OPANS LLC

Patients

Seq Age Sex Outcome Treatment
1 32 YR Male Other