MAUDE Adverse Event Report: OPANS, LLC. AMASSE BIO-FLUID DETECTION DEVICE; LABORATORY DEVELOPED TEST

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

Event Type  Injury  

Event Description

Opans llc in north carolina is selling their ldt(laboratory developed test) to the (b)(6) facilities to test individuals with and their not fda approved or cleared and it is ruining my life and countless others because it's validity is not only in question it is down right wrong 50% of the tests.It has stopped me from seeing my child for two months now and i'm sure it has made people lose their rights to their child along with imprisoned.It needs stopped right now.I have countless ways to prove it's incorrect.Full mass spectrometry urinalysis done the same exact day as their amasse self stick blood test was performed with dramatically different results.For a medical device to be so precise as their website states, the results themselves prove other wise.The results say you have fentanyl but no nor fentanyl it's metabolites, they say you have phosphatidylethanol (alcohol) but neither of it's metabolites in order to have phosphatidylethanol you'd have to be a chronic alcoholic, yet i take three drugs test every week and the only one that says i failed every week is the amasse self-stick blood test.I could pass a test on tuesday a mass spectrometry urinalysis and wednesday fail their amasse self-stick blood test and thursday pass another mass spectrometry urinalysis.This is going to make me lose my kid and i'm not doing anything wrong.In order for a lab to sell their ldt that has a blood collection tray of sorts that's you drop your blood into three little circle paper capture layers to be mailed through the mail (blood) to north carolina to opans llc to have a toxicology report done that says right on the results it is not fda approved or cleared is illegal.They are completely trumping the clia and breaking their rules of saying the device has to be approved by the fda and the fact it's a blood collection device that if was stolen in the mail your dna is now stolen and your life can be altered dramatically because of it's inaccurate results.Please help me.

Event Description

Additional information received from reporter on 09-jan-2024, for mw5117073.The entire state of (b)(6) is using an illegal device for testing at day report or community corrections, taking people kids and putting people behind bars using a device called the amasse biofluid blood test made by opans llc.That i've confirmed with the fda isn't in their database, if it's not fda approved it's being sold illegally, bought illegally and used illegally.The owner of the device (b)(6) says the main problem with the device is failure to dry the blood spot, in order to maintain chain of custody the seal it in the package while it's still wet, completely ignoring policy and procedures of toxicology.Stomping all over our rights.Rights to a fair trial are gone and it's an illegal search and seizure.Please stop this madness people are losing their family's or loved ones because of this device.Sincerely, we the people.It's not fda approved and it's being used to take kids and put people behind bars, this needs stopped now.

• Brand Name: AMASSE BIO-FLUID DETECTION DEVICE
• Type of Device: LABORATORY DEVELOPED TEST
• Manufacturer (Section D): OPANS, LLC.; 4134 south alston avenue; durham NC 27713
• MDR Report Key: 16818300
• MDR Text Key: 314130670
• Report Number: MW5117073
• 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,Followup
• Report Date: 04/18/2023

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
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/10/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 107 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White