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

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 12/25/2021

Event Type  malfunction  

Event Description

Quickvue rapid at home covid test- multiple false positives confirmed with pcr testing.Fda safety report id# (b)(4).

• Brand Name: QUICKVUE OTC AT HOME COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 13110748
• MDR Text Key: 282969476
• Report Number: MW5106308
• 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: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic