MAUDE Adverse Event Report: OXYCODONE URINE TEST

Device Problems False Positive Result (1227); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2015

Event Type  malfunction  

Event Description

(b)(4) is selling falsely advertised oxycodone urine tests.These are not oxycodone tests, but rather general opiate tests.It will test positive if any opiate is in your system.(b)(4) will not answer any of my messages, emails or letters regarding this issue and provided me with an incorrect address to return this product, which was returned to me twice.Lab tests showed no oxycodone in my urine, while (b)(4) tests showed oxycodone being in my system (after 2+ months after taking an oxycodone tablet).Which is impossible.

• Brand Name: OXYCODONE URINE TEST
• Type of Device: OXYCODONE URINE TEST
• MDR Report Key: 5124330
• MDR Text Key: 27476966
• Report Number: MW5056784
• Device Sequence Number: 1
• Product Code: DJG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Type of Device Usage: N
• Patient Sequence Number: 1