MAUDE Adverse Event Report: QUEST PRODUCTS, INC QUEST LABS AMPHETAMINE HAIR TEST; ENZYME IMMUNOASSAY, AMPHETAMINE

Device Problem False Positive Result (1227)

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

Event Date 07/23/2020

Event Type  malfunction  

Event Description

Patient called to report inaccurate results from a quest amphetamine hair test.Patient stated that she was taking vyvanse, wellbutrin, and bromfed cough medicine at the time of the test, which should not trigger a positive result.Patient said her test came back 90% positive for methamphetamine even though she has never used it.Patient stated she was told her medications were not the cause.Patient stated the test was not accurate and does not believe the tests are run properly.Patient mentioned that bromfed contains pseudoephedrine.Patient also stated she received a 192-page document package in (b)(6) 2022 in reference to the quest hair test which stated corrective actions were needed with her test sample.

• Brand Name: QUEST LABS AMPHETAMINE HAIR TEST
• Type of Device: ENZYME IMMUNOASSAY, AMPHETAMINE
• Manufacturer (Section D): QUEST PRODUCTS, INC
• MDR Report Key: 16684131
• MDR Text Key: 312935952
• Report Number: MW5116362
• Device Sequence Number: 1
• Product Code: DKZ
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female