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

Lot Number 3655546

Device Problem False Positive Result (1227)

Patient Problem Emotional Changes (1831)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

I took 3 otc covid tests over 3 days.All were quidel quickvue at-home covid-19 test.They were all from different boxes.I followed the directions exactly (i have a phd in chemistry and know how to be careful with laboratory testing).I received positive results from each of the 3 tests.After each tests, i went and received a pcr tests from 3 different sources; all 3 of these pcr tests were negative.Family members took the second test available in two of the boxes and both of those tests were negative.I clearly had something that was triggering the false positive result for the quickvue tests.Based on the results of the quickvue tests, i canceled a number of personal commitments, including one which incurred a (b)(6) cancellation fee.I also pulled one child from school and isolated from my family for 2 days until the second pcr test returned a negative result.Tests were conducted on (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: QUICKVUE AT-HOME COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 12834949
• MDR Text Key: 281009743
• Report Number: MW5105400
• 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: 11/15/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/05/2023
• Device Lot Number: 3655546
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: MONTELUKAST; MULTIVITAMIN; PROBIOTICS; PROTONIX; RESTASIS; VITAMIN D3
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian