MAUDE Adverse Event Report: 5 PANEL URINE DRUG SCREENS; ENZYME IMMUNOASSAY, AMPHETAMINE

Device Problems Use of Incorrect Control/Treatment Settings (1126); False Positive Result (1227)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/19/2019

Event Type  Injury  

Event Description

Otc and other substandard drug screens are being used on parents who take xr medications, in my case dextroamphetamine; zoloft; gabapentin; buprenorphine; trimethoprim/ sulfamethoxazole; alprazolam;, several that are known to commonly cause false positive results, these results are being used to remove children from their homes and to terminate parental rights making loss of employment more of a protected liberty interest than civil death.Laboratories are not provided lists of medications taken and refuse calls to otherwise inquire about testing, medications and false positives results.Screens are being completed absent any chains of custody, proper procedures, medical review officers, social worker are committing malpractice determining if the results are positive or negative beyond their scope of practice.No process is afforded to dispute these results and letters/notes from medical doctors and pharmacies are rejected.The fda warnings,cfr, samsha guidelines, good manufacturing practices are all being ignored for these substandard drug screens, thousands of families in (b)(6) are being impacted by this grace injustice.This is a public health crisis.Sample held and did not arrive until up till 20 days later at laboratory.And on some xr medications did not even test positive as should have, which is also used negatively.No confirmation is provided for urine samples, used in court without numerical values as per cfr.Almost times urine is negative while hair(not meant for persons taking xr meds) are positive.Fda safety report id# (b)(4).

• Brand Name: 5 PANEL URINE DRUG SCREENS
• Type of Device: ENZYME IMMUNOASSAY, AMPHETAMINE
• MDR Report Key: 15915401
• MDR Text Key: 304881711
• Report Number: MW5113599
• Device Sequence Number: 4
• Product Code: DKZ
• 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: 11/27/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: ALPRAZOLAM; BACTRIM; BUPRENORPHINE; DEXTROAMPHETAMINE; EPHEDRIZINE; GABAPENTIN; MULTIVITAMIN
• Patient Outcome(s): Disability; Required Intervention; Life Threatening
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White