MAUDE Adverse Event Report: POINT-OF-CARE URINE DRUG TEST (FENTANYL SCREEN); ENZYME IMMUNOASSAY, OPIATES

Medical Device Problem Codes	False Positive Result (1227); Use of Device Problem (1670)
Health Effect - Clinical Code	Distress (2329)
Date of Event	04/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
After routine monitoring at (b)(6), i was told i tested positive for fentanyl using a point-of-care test kit.I have never used fentanyl, and subsequent independent hair and urine toxicology on (b)(6) 2025 were both negative.The clinic refused to release confirmation or chain-of-custody documentation.Because of this false result, my medical record lists an inaccurate diagnosis of opioid use disorder, causing emotional distress and legal repercussions.I believe this may indicate an inaccurate or mishandled test device or result documentation.On (b)(6) 2025, a point-of-care urinalysis drug screen performed at (b)(6) reported a presumptive positive for fentanyl.I denied any fentanyl use and requested confirmatory laboratory testing (gc/ms or lc/ms), but none was performed or provided.The clinic refused to release chain-of-custody documentation for the sample.Later, on (b)(6) 2025, independent urine and hair toxicology testing were both negative for fentanyl.The unconfirmed positive result from (b)(6) 2025 was used to label me as having opioid use disorder.I am reporting this to note a potential accuracy or handling problem with the fentanyl test used.

• Brand Name: POINT-OF-CARE URINE DRUG TEST (FENTANYL SCREEN)
• Common Device Name: ENZYME IMMUNOASSAY, OPIATES
• MDR Report Key: 23479309
• Report Number: MW5178550
• Device Sequence Number: 14489540
• Product Code: DJG
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2025
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALBUTEROL INHALER-PRN ; TRAZODONE-PRN ; UBREVELY-PRN
• Outcome Attributed to Adverse Event: Disability; Other
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Race: White