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

Lot Number F41064

Device Problems Leak/Splash (1354); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

My quickvue covid test was defective.The tubes used for testing had leaked out all of the blue liquid.

• Brand Name: QUICK VUE AT HOME COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 16214562
• MDR Text Key: 307888941
• Report Number: MW5114390
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/17/2023

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: 02/16/2023
• Device Lot Number: F41064
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2023
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White