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

Model Number L031319-01

Device Problems Product Quality Problem (1506); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/21/2022

Event Type  malfunction  

Event 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
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 14800807
• MDR Text Key: 294939350
• Report Number: MW5110481
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 00682607660261
• UDI-Public: (01)00682607660261
• 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: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Patient Sequence Number: 1
• Treatment: 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