MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX ANTIGEN HOME TEST; OVER-THE-COUNTER COVID-19 ANTIGEN TEST

Lot Number COV3030009

Patient Problem Unspecified Infection (1930)

Event Date 02/13/2024

Event Type  Injury  

Event Description

I took a flowflex antigen home test.It was positive.I went to the urgent care and got a pcr (polymerase chain reaction) rvs.Both were negative.They asked me to do another at home and i did and it was positive.I did another pcr on wed.Neg.Thurs.Binaxnow neg.Friday binaxnow neg.I'm so glad i did not take the paxlovid.I have a bacterial infection.My boxes of flowflex say expire 2025, date (2) (b)(6), one (b)(6) on 1.Your website says 2024 for cov3030007 ov3030007 expire this month.This was a false positive i believe because the close expiration date being 2024 not 2025.Reference # mw5151805.

• Brand Name: FLOWFLEX ANTIGEN HOME TEST
• Type of Device: OVER-THE-COUNTER COVID-19 ANTIGEN TEST
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 18758704
• MDR Text Key: 336049860
• Report Number: MW5151804
• Device Sequence Number: 1
• Product Code: QYT
• 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: 02/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: COV3030009
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2024
• Patient Sequence Number: 1
• Treatment: AMLODIPINE.; BINAXNOW COVID TEST.; CALCIUM .; COQ10 .; LIPITOR "MYBECK".; MAGNESIUM.; POTASSIUM .; RESTASIS.; VITAMIN C .; VITAMIN D2.
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White