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

Lot Number 3648551

Device Problems False Positive Result (1227); Device Markings/Labelling Problem (2911)

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

Event Date 12/19/2021

Event Type  malfunction  

Event Description

I took a quickvue at-home covid test on (b)(6) 2021 in accordance with the directions on the package.The result was a very, very, very faint pink line, which the package directions say indicate a positive test.I took a follow-up pcr test on (b)(6) 2021.The result was negative.The result from the quickvue test was a false positive.Test ref.Number from package: (b)(4), test lot number from package: 3648551, test expiration date from package: 2023-06-07.Fda safety report id# (b)(4).

• Brand Name: QUICKVUE AT-HOME COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 13076882
• MDR Text Key: 282815714
• Report Number: MW5106241
• 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: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/07/2023
• Device Lot Number: 3648551
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: DEPO-PROVERA; LEVOTHYROXINE; MULTIVITAMIN ; VITAMIN D
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White