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

Lot Number 148866

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

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

Event Date 08/27/2022

Event Type  malfunction  

Event Description

[quickvue at-home otc covid-19 test] use for covid-19 under emergency use authorization (eua): failure to meet performance specifications (including labeling claims) or failure to perform as intended - medical devices.Test purchased recently with expiration date of june 2023.The patient is my wife.I am emeritus professor of medicine at (b)(6) college of medicine.We had a recent possible exposure to someone with symptomatic covid; tested negative with binax test at 24 hours.My wife was asymptomatic.Re-tested with quickvue as above 5 days later.Result: positive.I, 72 years old, asymptomatic, also tested neg with binax at 24 hrs, on retest at 5 days, quickvue, same box, tested positive.That same day i repeated rat (rapid antigen test) with binax, it was neg.We both had pcr nasal swabs 5 hrs later.Both pcr tests negative.Hence the quickvue test for both of us was a false positive.

• Brand Name: QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 15328043
• MDR Text Key: 299184976
• Report Number: MW5111811
• Device Sequence Number: 2
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 08/29/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/06/2023
• Device Lot Number: 148866
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: BINAX NOW COVID TEST
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White