MAUDE Adverse Event Report: QUEST DIAGNOSTICS HAIR OF ABUSE DRUG TEST LDT; LABORATORY DEVELOPED TEST

Model Number 37004N

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

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

Event Date 02/28/2024

Event Type  malfunction  

Event Description

I took a hair test collected in (b)(6) and sent to kansas lab- quest diagnostics.On the labs website it states cutoff was 500pg and confirmation 500pg.The test i took was initial cutoff 500pg and confirmation 250pg.Additionally the chain of custody was inaccurate as the test has no collection time and their is no shipping and transport information.These tests need to be regulated or taken off the market.

Event Description

Additional information received on 5/23/2024 for report mw5152465 to update manufacturer.

• Brand Name: HAIR OF ABUSE DRUG TEST LDT
• Type of Device: LABORATORY DEVELOPED TEST
• Manufacturer (Section D): QUEST DIAGNOSTICS
• MDR Report Key: 18858211
• MDR Text Key: 337371145
• Report Number: MW5152465
• 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: 03/05/2024

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
• Device Model Number: 37004N
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2024
• Patient Sequence Number: 1
• Treatment: ADDERALL .; MUCINEX D.; TAMIFLU.
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 46 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native