• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

QUIDEL CORPORATION QUIDEL QUICKVUE LFA COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameQUIDEL QUICKVUE LFA COVID TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORPORATION
MDR Report Key13141642
MDR Text Key283154106
Report NumberMW5106395
Device Sequence Number1
Product Code QKP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number3662035
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 12/30/2021 Patient Sequence Number: 1
Treatment
AS NEEDED BENADRYL; IBUPROFEN; IMITREX; TYLENOL; ZYRTEC
-
-