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

Device Problems False Positive Result (1227); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2022

Event Type  malfunction  

Event Description

Bottomline: reporting two false positives of acon flowflex antigen home test (in white box) on (b)(6) 2022 on the morning of (b)(6) 2022, i administered my weekly covid-19 rapid test (acon flowflex antigen home test) and tested positive.I've taken this test near-weekly for 10-12 weeks and always tested negative.Immediately following my flowflex positive on 2022, i administered an abbott binaxnow covid-19 test, which came back negative.Now concerned that the tests may be showing different results, i tested with a second flowflex (again, white box), which produced a faint positive.At this point, i scheduled a pcr at (b)(6) and received it also on the morning of (b)(6) 2022 (2-3 hours after my series of at-home tests).On the morning of (b)(6) 2022, i again tested with the binaxnow, which showed negative.When my pcr results were returned to me this morning ((b)(6) 2022), they were also negative.I'm reporting this as i know there is a known issue (per the fda) with acon flowflex sars-cov-2 antigen rapid test (blue box), and should there also be a critical mass of false positives with their other test - wanted to at least add to that awareness.Thank you for your time.Photo shows tests in order.The two flowflex tests are #1 (still shows positive line) and #3 (no longer showing faint positive, but it was there).Fda safety report id # (b)(4).

• Brand Name: FLOWFLEX ANTIGEN HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 14521881
• MDR Text Key: 292976965
• Report Number: MW5109947
• Device Sequence Number: 2
• Product Code: QKP
• 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: 05/24/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: CHONDROITIN COLLAGEN ATHLETIC GREENS; VITAMIN C AND D GLUCOSAMINE
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White