MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFEX COVID-19 ANTIGEN HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number L031-1185

Device Problem Inadequate Instructions for Non-Healthcare Professional (2956)

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

Event Date 05/28/2022

Event Type  malfunction  

Event Description

I used the flowfex covid-19 antigen test and found the instructions to be difficult to follow and easy to mess up.I have had a long professional life in the computer industry and these instructions are among the worst i have ever seen.

• Brand Name: FLOWFEX COVID-19 ANTIGEN HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 14574441
• MDR Text Key: 293281629
• Report Number: MW5110018
• 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
• Type of Report: Initial
• Report Date: 05/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: L031-1185
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White