MAUDE Adverse Event Report: QUEST DIAGNOSTICS A LDT / QUEST INTL., INC. HAIR TEST; LABORATORY DEVELOPED TEST

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

Event Date 02/22/2024

Event Type  Injury  

Event Description

Once again i took a hair test and urine test that were sent to quest labs.The hair test came back positive for a drug i do not use.So, i took another hair test 5 days later and it came back negative.I then took a third hair test 5 days later and it came back negative.However, i lost custody of my son due to these absolutely inaccurate tests.Why is the fda, cap and clia allowing this to happen.Parents should not loose custody due to laboratory errors and unreliable hair tests.

• Brand Name: HAIR TEST
• Type of Device: LABORATORY DEVELOPED TEST
• Manufacturer (Section D): QUEST DIAGNOSTICS A LDT / QUEST INTL., INC.
• MDR Report Key: 19097245
• MDR Text Key: 340197522
• Report Number: MW5153794
• 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
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 48 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White