MAUDE Adverse Event Report: OPANS LLC PATENTED AMASSE DEVICE; LABORATORY DEVELOPED TEST

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

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.

• Brand Name: PATENTED AMASSE DEVICE
• Type of Device: LABORATORY DEVELOPED TEST
• Manufacturer (Section D): OPANS LLC
• MDR Report Key: 18486828
• MDR Text Key: 332910755
• Report Number: MW5150091
• Device Sequence Number: 1
• Product Code: OQS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White