Description of Event or Problem · 0
ON (B)(6) 2021 I VISITED (B)(6) HOSPITAL; (B)(6) FOR PRE-OP TESTING DUE TO AN OUTPATIENT PROCEDURE TO BE PERFORMED ON TUESDAY (B)(6) 2021. PART OF PRE OP TESTING WAS OF COURSE A COVID-19 TEST. THE HOSPITAL USED A RAPID SOFIA ANTIGEN SWAB TEST WHICH TESTED POSITIVE AND THE STAFF ADVISED THAT THEY WOULD HAVE TO CANCEL MY SCHEDULED PROCEDURE FOR THE FOLLOWING DAY. IN ADDITION, WITH IN 30 MINUTES I RECEIVED A CALL FROM THE HEALTH DEPARTMENT REGARDING CONTACT TRACING AND ADVISING ME TO QUARANTINE FOR 14 DAYS. KNOWING I WAS NOT POSITIVE AND AM A PRIOR CANCER PATIENT OF 2017, IN REMISSION, AND STILL TAKING CANCER MEDICATIONS FOR MY TREATMENT PLAN, I DEMANDED A SECOND TEST BE COMPLETED. I REQUESTED THE PCR TESTING BE DONE IN THE LAB. THE RESULTS CAME BACK NEGATIVE. SO, OBVIOUSLY THESE COVID SWAB ANTIGEN TESTS ARE NOT SO VERY ACCURATE. AS A PATIENT, OUR LIVES ARE IN THE HANDS OF THESE HEALTH CARE PROVIDERS. KNOWING MY HEALTH HISTORY AND OBVIOUSLY KNOWING THE EXTENSIVENESS OF HOW EACH OF THESE TESTS WORK, WHY WOULD THEY USE A SOFIA ANTIGEN METHOD VERSES THE PCR METHOD? IF THESE TESTS ARE NOT ACCURATE WHY ARE THEY BEING USED? TO INFLATE POSITIVE NUMBERS TO THE CDC AND FALSIFY INFORMATION? AFTER COMPLETING MY PCR TEST AND RECEIVING A NEGATIVE, WAS THAT REPORTED BACK TO CONTACT TRACING AND THE FALSE POSITIVE RESULT REMOVED? THE SYSTEM IS BROKEN. THE FDA NEEDS TO BE AWARE OF WHAT'S GOING ON IN THESE HEALTH CARE FACILITIES. IF I WASN'T SMARTER THEN THE AVERAGE PATIENT AND HAD KNOWLEDGE OF THIS MATTER, MY WHOLE WORLD WOULD HAVE CHANGE IN 24 HOURS DUE TO NEGLIGENCE AND FALSE PRODUCTS BEING USED. I WILL ALSO BE SENDING NOTIFICATION TO THE ADMINISTRATION BOARD OF THE HOSPITAL FACILITY REGARDING THIS MATTER AND THE MANNER IN WHICH IT WAS HANDLED. ASKING THAT THIS BE REVIEWED AND PRODUCT BEING USED AT THIS FACILITY BE LOOKED AT OR ADDITIONAL TRAINING BE PROVIDED TO THE STAFF USING THIS PRODUCT. FDA SAFETY REPORT ID # (B)(4).