MAUDE Adverse Event Report: IMMONOASSY TEST; ENZYME IMMUNOASSAY, AMPHETAMINE

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Compatibility Problem (2960)

Patient Problem Insufficient Information (4580)

Event Date 08/27/2021

Event Type  malfunction  

Event Description

Biotin interference drug test; serious legal implications with biotin interference probation urine drug tests.The (b)(6) court in (b)(6) uses (b)(6) to analyze all urine drug screens and confirmatory lc ms/ms tests.(b)(6) has done nothing to mitigate biotin interference in their emit, eia and elisa biotinlayden competitive immunoassay urine drug screens.They have also done nothing to ensure biotin interference has not effected urine drug lc ms/ms testing.I have been taking biotin 30 mg's a day for almost 2 yrs with my doctors supervision.According to the current research my daily intake of biotin would definitely cause interference with all biotinlayden immunoassays.I also am prescribed trazodone and use an otc nasal decongestant spray due to congestion from nightly cpap use.I do not use any illicit drugs and never have.My immunoassay urine drug screen results have had outrageously high levels of amphetamine and methamphetamines and the lc ms/ms confirmatory tests have outrageously high analyte values as well.I have taken urine drug screens at the (b)(6) hospital on the same day as the cordant tests.The sometimes the results from the (b)(6) drug screens were negative for amp/mamp and sometimes the results were positive.The (b)(6) conducted gc ms tests from on the same day as the lc ms ms tests with the urine collection times less than 30 minutes apart.The (b)(6) gc ms results were 2278 amp and 23396 mamp.The cordant lc ms ms results were 845 amp 7075 mamp.The difference in analyte values are profound.L and d isomer tests were not conducted at all ever on any test.I will be facing serious legal problems this biotin interfere with my test results.This issue actually has very far reaching legal implications for thousand of people on probation and also people that must take drug test for health and human services.(b)(6) judges parole officers, probation officers and health and human services caseworkers should absolutely know about biotin interference but this issue is unknown and when i called attention to it.The information was not taken seriously.I've spoke to several medical professionals about this issue and not one of them knew anything about it.(b)(6) has done nothing and will not return my phone calls or emails.Biotin interference caused false elevated analyte values in urine samples.The biotin caused my prescription trazodone to cross react to amphetamine and the nasal spray i use which contains l-isomer methamphetamine analytes were raised to levels that are only usually seen in illicit drug use.My ua's were false positives for amphetamine/methamphetamine because of the false extremely high analyte values of my trazodone cross reacted to amphetamine and my nasal spray which has the exact same chemical signature as illicit methamphetamine.Cordant health solutions has not adhered to fda warnings to mitigate biotin interference and will not communicate with me about this issue.Thousands of people can potentially be affected by biotin with very serious life altering implications and know absolutely nothing about it.Fda safety report id# (b)(4).

• Brand Name: IMMONOASSY TEST
• Type of Device: ENZYME IMMUNOASSAY, AMPHETAMINE
• MDR Report Key: 12547558
• MDR Text Key: 274263196
• Report Number: MW5104279
• Device Sequence Number: 1
• Product Code: DKZ
• 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: 09/27/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 91