MAUDE Adverse Event Report: THYROID TESTING INTERFERRENCE; FREE THYROXINE TEST SYSTEM

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Type  No Answer Provided  

Event Description

I take 100mg biotin tid for ppms.I had routine labs done and thyroid tests indicated thyroid storm.I got a frantic call from office to come right in.I had no symptoms and was not at all close to the office.I am a disabled nurse practitioner and knew the critical labs did not correlate to my physical status.I let my pcp know that i would hold the biotin and get the labs repeated and to cancer the nuclear med scan and ultrasound testing.The repeat labs were perfectly normal.If i had not done my due diligence, i coudl have ended up getting my thyroid irradiated and been put on lifelong meds that would then be necessary.Please make sure that thyroid testing interference is added to your alerts.Although i was not injured, i easily could have been.I saw your alert yesterday anout troponin and wanted to respond.Thank you for making this problem known.(b)(6).

• Brand Name: THYROID TESTING INTERFERRENCE
• Type of Device: FREE THYROXINE TEST SYSTEM
• MDR Report Key: 7079162
• MDR Text Key: 93827525
• Report Number: MW5073722
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 69