MAUDE Adverse Event Report: QUIDEL CORPORATION QUIDEL QUICKVUE LFA COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 3662035

Device Problem False Positive Result (1227)

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

Event Date 12/23/2021

Event Type  malfunction  

Event Description

Without symptoms and in anticipation of travel, took quidel quickvue covid lfa test on (b)(6) 2021.Positive test result.I repeated immediately with positive result again.Four (4) household members took test with same serial number and received negative results.Repeated quidel quickvue test with different serial number on (b)(6) 2021 and received 3rd positive result.Received pcr tests on (b)(6) 2021 and (b)(6) 2021 at different facilities with negative results.I reported to quidel on (b)(6) 2021 and company reported that investigating false positive test results for individuals with autoimmune conditions of rheumatoid arthritis and lupus.Reported that i have been diagnosed with sjogren's syndrome, graves disease and hashimoto's in past and currently have elevated autoimmune antibodies.Reporting because potential inaccuracy creates unreliability.I can be reached at (b)(6).Negative pcr on (b)(6) 2021 and (b)(6) 2021.I have autoimmune issues.Fda safety report id# (b)(4).

• Brand Name: QUIDEL QUICKVUE LFA COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 13141642
• MDR Text Key: 283154106
• Report Number: MW5106395
• 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: 12/29/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/03/2023
• Device Lot Number: 3662035
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: AS NEEDED BENADRYL; IBUPROFEN; IMITREX; TYLENOL; ZYRTEC
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White