FDA Adverse Event Injury Summary report: N

POINT-OF-CARE URINE DRUG TEST (FENTANYL SCREEN)

MDR report key: 23479309 · Received November 5, 2025

Report

Report Number
MW5178550
Event Type
Injury
Date Received
November 5, 2025
Date of Event
April 2, 2025
Report Date
October 31, 2025
Manufacturer
UNK
Product Code
DJG
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IN, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2280894 POINT-OF-CARE URINE DRUG TEST (FENTANYL SCREEN) ENZYME IMMUNOASSAY, OPIATES DJG UNK

Patients

Seq Age Sex Outcome Treatment
1 31 YR Female Disability| O ALBUTEROL INHALER-PRN | TRAZODONE-PRN | UBREVELY-PRN