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

Lot Number F40655

Device Problems False Positive Result (1227); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  malfunction  

Event Description

Quidel quickvue covid test gave me a false positive twice.Pcr test and rapid test from roche tested negative.This company has multiple complaints online.False positives are rare.(b)(4).

• Brand Name: QUICKVUE AT-HOME OTC COVID 19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 15094049
• MDR Text Key: 296572385
• Report Number: MW5111072
• Device Sequence Number: 1
• Product Code: QKP
• UDI-Device Identifier: 1461333972
• UDI-Public: 1461333972
• 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: 07/20/2022
• 2 Devices were Involved in the Event: 1 2

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: 01/07/2023
• Device Lot Number: F40655
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White