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

Lot Number F41105

Device Problems Product Quality Problem (1506); Component Missing (2306)

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

Event Date 01/23/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023 i was following the directions, which game in the quickvue at home covid test kit.I had finished swabbing each nostril according to step 4, and placed the swab into the tube with the reagent fluid for 1 minute.In step 5, i had to remove swab from the tube.Then put the test strip into the reagent fluid.But there was no reagent fluid left inside the tube.I was not able to complete the test for covid.Because there was a small amount of reagent fluid inside the two tubes.The mfr quidel, needs to add more reagent fluid to the tubes in the quickvue at-home covid test kit.So a person can get accurate test results.If you have any questions please contact me at (b)(6), or email (b)(6).Thank you.

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 16246680
• MDR Text Key: 308302402
• Report Number: MW5114502
• 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: 01/23/2023
• 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 Operator: Lay User/Patient
• Device Expiration Date: 02/26/2023
• Device Lot Number: F41105
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2023
• Patient Sequence Number: 1
• Treatment: ACITRETIN 25 MG; HYROCORTISONE 2.5% OINTMENT; LISINOPRIL (40MG); VERAPAMIL 120 MG; VITAMIN D3 ("1000 UT")
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American