MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOW FLEX; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number L031-118B5

Device Problem False Negative Result (1225)

Patient Problems Erythema (1840); Fever (1858); Pain (1994); Burning Sensation (2146); Swelling/ Edema (4577)

Event Date 09/01/2022

Event Type  Injury  

Event Description

I woke up not feeling well and immediately went to my pharmacy and purchased 3 covid19 antigen test.Flowflex was my only option.I returned home, thoroughly read the directions and began the test.As soon as the swab entered the appropriate area of my nasal cavity there was an immediate intense burning sensation that made me feel as if i had just put chemicals up my nose.My eye on the same side began to uncontrollably tear and water.I swabbed for the complete time and removed the swab.It was in so much pain i'm not quite sure how i forced myself to insert the swab into my other nostril.I did and the same excruciating pain occurred, once again feeling as if i was rubbing a chemical in my nose.Same tearing and watering from my other eye.I followed the remainder of the instructions and completed the test.I read my results after 15 minutes, 20 minutes, 25 minutes, and 30 minutes - negative.A negative result was a bit of a relief but i still knew something was going on by the way i was feeling.Now, in addition to not feeling well, i had a burning sensation in each nostril with both sides feeling swollen.Since my one and only experience with testing for covid (prior to this time) was at a cvs drive thru early on, i wasn't understanding the burning swollen nose side effect.After taking the flowflex test and getting the negative result, i continued to feel worse throughout the day.Each time i took my temperature it was elevated from the time before.Approximately 10 hours after my negative test result my temp was 103.8 degrees.Early the following morning a friend dropped off 2 binaxnow tests.I immediately took a test, experienced no pain/burn/chemical feel in either nostril.The test result showed positive.After a negative flowflex result and accompanying burning/swelling with an extremely high temp to a positive binax test approximately 16 hours later i feel there is something potentially dangerous with the flowflex test kits.Now, 3 days after the flowflex test i am experiencing a lot of pain in my nose with both sides being very red and swollen.Fda safety report id# (b)(4).

• Brand Name: FLOW FLEX
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 15379878
• MDR Text Key: 299584231
• Report Number: MW5111903
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00682607660261
• UDI-Public: 00682607660261
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/08/2023
• Device Model Number: L031-118B5
• Device Catalogue Number: 660261
• Device Lot Number: COV2020062
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White