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

Lot Number COV3030009

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/28/2023

Event Type  malfunction  

Event Description

My husband knew he had covid, was heavily exposed and symptomatic (same symptoms as his first case).We tested 4 times with flowflex with 3 different expiration dates, last of which was 3/27/2025.He tested negative.Our son, from whom he got covid, was sent ihealth test kit by kaiser for his test.So we ordered the ihealth kit, and within 24 hours of a flowflex test negative, (b)(6) tested positive.This info needs to go somewhere, be entered into a database somewhere as public health info.Please advise.Flowflex fails to detect at least one variant.Tried to take a picture of the 2 brands and ihealth 2 results (one negative mine, accurate) and one finally positive of my husband (accurate).After 4 failures by flowflex (no picture of that), just the kind of box was jpg and i think it did not work.Thanks.(b)(6).Reference report #mw5145362, #mw5145363, #mw5145364.

• Brand Name: FLOWFLEX
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 17710575
• MDR Text Key: 323053146
• Report Number: MW5145361
• Device Sequence Number: 1
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 09/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: COV3030009
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: LIPITOR
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White