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

Model Number	L031319-01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The dropper top of the squeeze tube that is used to apply the specimen directly to the test cartridge, malfunctioned.Instead of the specimen dripping out of the dropper into the specimen window easily, the specimen fluids started bubbling out of the sides where the plug part of the lid is supposed to fit securely into the tube.The dropper hole must not have been opened during manufacturing process and it caused a mess of my fluids and the mixture to go all over, and nothing into the window.Home test done.Doesn't have high or low ranges.Malfunction of the test may have not allowed enough specimen into the control window to produce accurate results.Fda safety report id# (b)(4).

• Brand Name: ACON COVID-19 ANTIGEN HOME TEST
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 14800807
• Report Number: MW5110481
• Device Sequence Number: 4844245
• Product Code: QKP
• UDI-Device Identifier: 00682607660261
• UDI-Public: (01)00682607660261
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/27/2022
• Device Model Number: L031319-01
• Device Catalogue Number: 660261
• Device Lot Number: COV1120195
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2022
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HALLS COUGH DROPS; IBUPROFEN ; METFORMIN ; PRO AIR INHALER FOR CONGESTION; RUSVASTATIN ; VENLAFAXINE
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White