MAUDE Adverse Event Report: DRUG TEST ENZYME, IMMUNOASSAY

Model Number REF# 6576843-0438

Device Problem False Positive Result (1227)

Patient Problem No Code Available (3191)

Event Date 07/20/2018

Event Type  No Answer Provided  

Event Description

I took a drug test, and it came up as ¿positive¿ for fentanyl. Thank god, my doctor and staff realized it was myrbetriq showing a false positive as fentanyl. They were looking at me as if i was a drug addict. Might want to put a warning on the box or send out notices to all drs. Myrbetriq ¿ overactive bladder medicine -- shows up as fentanyl on a drug test. Thank you, (b)(6).

• Brand Name: DRUG TEST
• Type of Device: ENZYME, IMMUNOASSAY
• MDR Report Key: 7739372
• MDR Text Key: 115909601
• Report Number: MW5078757
• Device Sequence Number: 1
• Product Code: DJG
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/28/2018

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/31/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: No
• Device Operator: NO INFORMATION
• Device MODEL Number: REF# 6576843-0438
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated By Manufacturer?

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient TREATMENT DATA

Date Received: 07/31/2018 Patient Sequence Number: 1