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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

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COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem False Positive Result (1227)
Patient Problem Fever (1858)
Event Type  malfunction  
Event Description
Pretty sure i had covid-19 "(b)(6)". I had fever for a couple of days and lost my sense of taste/smell. I got tested a couple of days after i lost the symptoms and tested negative. I got tested a couple more times the following week and all were negative results. Went to (b)(6) to get tested a couple of days ago on the (b)(6) and tested positive (got my results yesterday). I did a couple of rapid tests (yesterday and today) and both were negative results. So i believe my test from (b)(6) was a false positive. Fda safety report id# (b)(4).
 
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Brand NameCOVID TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
MDR Report Key13343973
MDR Text Key284510944
Report NumberMW5106949
Device Sequence Number1
Product Code QKP
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 01/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

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