MAUDE Adverse Event Report: BAJA COSMETICS QUIDEL QUICKVUE AT-HOME OTC COVID-19 TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 04/13/2022

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 12/29/2022

Event Type  malfunction  

Event Description

At home covid test made by quidel "quickvue at-home otc" that the usps just sent me had low amount of reagent in the vials.Lot 2204009; 2023-03-27, 2022-04-13.The tip of the swab is the only part that is touching the reagent.The swab sucks up everything and i cannot stir the swab.To get any liquid out, i have to scrape the swab against the vial top.Enough liquid comes out so the test stick absorbs the liquid.But both tests came back negative.When i switched to the binax test kit, the test result was positive.Covid test kit.Not a drug.

• Brand Name: QUIDEL QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): BAJA COSMETICS
• MDR Report Key: 16131560
• MDR Text Key: 307076461
• Report Number: MW5114234
• Device Sequence Number: 2
• 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: 01/07/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 04/13/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2023
• Patient Sequence Number: 1
• Patient Sex: Female