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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. BINAXNOW; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
Device Problem False Negative Result (1225)
Patient Problem Viral Infection (2248)
Event Date 11/22/2022
Event Type  malfunction  
Event Description
I was tested at my hospital's urgent care team with an antigen test on (b)(6) 2022 with a negative result while exhibiting covid19 symptoms.Then, i tested negative again with an antigen test bought from walgreens on (b)(6) 2022.Then, on (b)(6) 2022, i tested at synergy wellness with their pcr test and the result was positive for covid19 but symptoms were less severe.On the same day (b)(6) 2022 that i tested positive for covid with their pcr test, i tested again with an at home antigen test that was negative.The antigen tests are not working.Fda claims they are accurate 80% of the time; however, this is not the case with as many tests as i have done while having proof i was positive.I tested a total of 5 times with my over-the-counter (and urgent care's) antigen tests and they were all negative while actually being pcr positive.I purchased 6 rapid tests over the counter and all were negative while i was showing covid19 symptoms and while i as actively positive for covid-19 with synergy wellness' pcr test.Fda safety report id# (b)(4).
 
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Brand Name
BINAXNOW
Type of Device
CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
MDR Report Key15893419
MDR Text Key304699555
Report NumberMW5113538
Device Sequence Number3
Product Code QKP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/28/2022
6 Devices were Involved in the Event: 1   2   3   4   5   6  
1 Patient was Involved in the Event
Date FDA Received11/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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