MAUDE Adverse Event Report: HAIR FOLLICLE TEST; ENZYME IMMUNOASSAY, AMPHETAMINE

Device Problem Insufficient Information (3190)

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

Event Date 08/23/2020

Event Type  malfunction  

Event Description

Drug testing; wellbutrin is showing a positive for methamphetamines' in my hair follicle tests.Wellbutrin showing positive for methamphetamine.Fda safety report id # (b)(4).

• Brand Name: HAIR FOLLICLE TEST
• Type of Device: ENZYME IMMUNOASSAY, AMPHETAMINE
• MDR Report Key: 12954631
• MDR Text Key: 281978279
• Report Number: MW5105880
• Device Sequence Number: 1
• Product Code: DKZ
• Combination Product (y/n): Y
• 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: 12/02/2021

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2021
• Patient Sequence Number: 1
• Treatment: PSEUDOEPHEDRINE; VYVANSE; WELLBUTRIN
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White