• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

UNKNOWN TSH TESTS RADIO IMMUNOASSAY, THYROID-STIMULATING HORMONE Back to Search Results
Device Problem Incorrect, Inadequate or Imprecise Resultor 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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTSH TESTS
Type of DeviceRADIO IMMUNOASSAY, THYROID-STIMULATING HORMONE
Manufacturer (Section D)
UNKNOWN
MDR Report Key8894659
MDR Text Key154466361
Report NumberMW5089053
Device Sequence Number1
Product Code JLW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received08/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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: 08/13/2019 Patient Sequence Number: 1
-
-