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

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 01/25/2023

Event Type  malfunction  

Event Description

Quickvue at home covid 19 test lot 3695337, expiration 2023-08-03.Tested as instructed.Invalid tests.Not enough fluid in tube to reach control line or produce any result after instructed 10 minutes.Tested positive with flowflex, binax, and in doctor's office.

• Brand Name: QUICKVUE AT HOME COVID 19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 16253391
• MDR Text Key: 308360263
• Report Number: MW5114518
• 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: 01/25/2023

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/03/2023
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White