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

Device Problem False Positive Result (1227)

Patient Problem Vomiting (2144)

Event Date 12/24/2022

Event Type  malfunction  

Event Description

Took a quidel quickvue at-home otc covid-19 (rapid antigen) test and got a false positive test.Re tested twice with another brand and both covid-19 tests were negative.Repeated testing caused vomiting.

• Brand Name: QUIDEL QUICKVUE AT-HOME OTC COVID-19 (RAPID ANTIGEN) TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 16121551
• MDR Text Key: 307002422
• Report Number: MW5114210
• 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: 01/04/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/06/2023
• Patient Sequence Number: 1
• Treatment: FLOWFLEX COVID-19 ANTIGEN HOME TEST
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White