TB GOLD

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-08 for TB GOLD manufactured by .

Event Text Entries

[35992564] I am a patient receiving biologics treatment for rheumatoid arthritis. With the lowering of my ability to infection by rheumatologist ordered a (b)(6) blood test for (b)(6) even though i had passed a skin patch test three months previously with my personal physician. The test, which i had to pay for personally, came back (b)(6). My rheumatologist ordered the test again, at my expense, and again the same results. My rheumatologist started me on medication, ihs, and referred me to an infection disease doctor while requesting another (b)(6) test. Again at my expense and same results. After a year of treatment, i was given orders for a chest x-ray, discharged from the infection disease specialist and returned to begin treatment for my rheumatoid arthritis. Nothing was ever mentioned about this again. In (b)(6) 2015 i was surprised that my new rheumatologist had ordered a (b)(6) when i went for my monthly blood work due to the knowledge that i would test (b)(6). I know that from the initial diagnosis i would have to have chest x-ray to determine if my (b)(6) was active. Hence my surprise when my rheumatologist informed me that my (b)(6) was (b)(6). I told him that i was tested in 2012 three times and went through a year of therapy along with chest x-rays for tuberculosis to which he informed me that the interception of the (b)(6) test it had problems and i might have been part of that group. I am upset that this information was not released to its victims. I went through unnecessary medical treatment and exposed unnecessarily to x-ray for a faulty test, which i had to pay. I would like to know more about this.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5059331
MDR Report Key5366291
Date Received2016-01-08
Date of Report2016-01-08
Date of Event2016-01-07
Date Added to Maude2016-01-14
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTB GOLD
Generic NameTB GOLD
Product CodeNCD
Date Received2016-01-08
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2016-01-08

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