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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DRUG TEST ENZYME, IMMUNOASSAY

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DRUG TEST ENZYME, IMMUNOASSAY Back to Search Results
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).

 
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Brand NameDRUG TEST
Type of DeviceENZYME, IMMUNOASSAY
MDR Report Key7739372
MDR Text Key115909601
Report NumberMW5078757
Device Sequence Number1
Product Code DJG
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
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 Received07/31/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL NumberREF# 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
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