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

Catalog Number 20402

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Difficult to Setup or Prepare (1487); Difficult to Open or Close (2921)

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

Event Date 11/29/2022

Event Type  malfunction  

Event Description

On 2 of 3 test kits, reagent vial could not be opened, and i was unable to perform test.I opened another kit and used it to test.I called quidel inc., at (b)(4) and reported issue to rep(b)(4).He suggested i use pliers to open the vial! i asked him if this instructions for use was cleared by fda, and why this instruction was not included in the user instructions.I was unable to get replacement kit or vials without providing my email address.I did not find the phone call to be helpful.Fda safety report id# (b)(4).

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 15905980
• MDR Text Key: 304867236
• Report Number: MW5113576
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 14613339723
• UDI-Public: 14613339723
• 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: 11/29/2022
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/17/2023
• Device Catalogue Number: 20402
• Device Lot Number: N2E2607
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian