MAUDE Adverse Event Report: QUEST DIAGNOSTICS INC. QUEST LABS HAIR TEST OVER THE COUNTER LDT; ENZYME IMMUNOASSAY, AMPHETAMINE

Model Number 5977 AGILENT

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

Patient Problem Emotional Changes (1831)

Event Date 09/20/2021

Event Type  Injury  

Event Description

Took a hair drug test and showed positive for methamphetamine a drug i do not use.Does not matter to a court, my life has been ruined by this! confirmatory test showed d-meth.

Event Description

Additional information received on 12/15/2023 for report mw5147020 to update the manufacturer to quest diagnostics, inc.

• Brand Name: QUEST LABS HAIR TEST OVER THE COUNTER LDT
• Type of Device: ENZYME IMMUNOASSAY, AMPHETAMINE
• Manufacturer (Section D): QUEST DIAGNOSTICS INC.; 10101 renner blvd; lenexa, KS 66219 9752
• MDR Report Key: 17949584
• MDR Text Key: 326005307
• Report Number: MW5147020
• Device Sequence Number: 1
• Product Code: DKZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5977 AGILENT
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: WELLBUTRIN AND VYVANSE. QUEST LABS FLAWED HAIR TEST.
• Patient Outcome(s): Disability; Other
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic
• Patient Race: American Indian Or Alaskan Native