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

Lot Number 3686002

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

The quickvue at home covid test didn't have but a drop of blue liquid in vials.The picture showed it with blue liquid 1/3rd of way up tube.The liquid didn't even cover the bottom of swab's end tip when inserted into vial.Nothing like picture showed covering swab.Fda safety report id# (b)(4).

• Brand Name: QUICKVUE AT HOME COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 15282611
• MDR Text Key: 298585387
• Report Number: MW5111659
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 3686002
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White