MAUDE MDR 5366291

MDR report key
5366291
Report number
MW5059331
Event key
0
Event type
3
Date of event
2016-01-07
Date received
2016-01-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TB GOLDTB GOLDNCD* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-01-0801. O; 2. S

Event Narratives#

D

Patient 1

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.