MAUDE Adverse Event Report: UNKNOWN TSH TEST; RADIO IMMUNOASSAY, THYROID-STIMULATING HORMONE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Thyroid Problems (2102); Underdose (2542); Test Result (2695)

Event Date 07/01/2019

Event Type  Injury  

Event Description

A tsh test was ordered by my va provider.The test resulted in my synthroid rx being reduced.The tsh was below detectable limits.This is the second test showing such a result.I stopped taking biotin to be sure this was not the problem.It is not.I have been told of others being taken completely off their thyroid medication based on these tests since 2015.Thyroids do not miraculously heal, unless it is medication driven.I take no other rx.My hyperthyroid symptoms have returned, this generation of tsh is appropriate for screening, but not for clinical evaluation of on-going thyroid replacement management.I am enclosing only approximate dates of testing.Two consecutive test below the detectable limit.My previous dosage of synthroid was "adjusted" in 2011.They thyroid hormone does not improve with menopause, it worsens.Therefore, i conclude with my symptoms, these tests are inadequate for medication adjustment.Two different laboratories.Fda safety report id # (b)(4).

• Brand Name: TSH TEST
• Type of Device: RADIO IMMUNOASSAY, THYROID-STIMULATING HORMONE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8894659
• MDR Text Key: 154466361
• Report Number: MW5089053
• Device Sequence Number: 2
• Product Code: JLW
• 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: 08/12/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 51 YR
• Patient Weight: 50