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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2021

Event Type  malfunction  

Event Description

I began having a sore throat before the holidays and knew i was in a place of covid-19 exposure.Multiple people, i was with tested positive and had symptoms.I immediately began getting tests and had inaccuracies throughout the week.I wanted to report this so you have a record of some of these tests.I've had 3 negative test results and 3 positive test results.Covid-19 testing kits.Fda safety report id# (b)(4).

• Brand Name: QUIDEL QUICKVUE AT-HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 13110543
• MDR Text Key: 282974880
• Report Number: MW5106304
• 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: 12/26/2021
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: IBUPROFEN ; IUD; SALINE SOLUTION ; SUDAFET; VENLAFAXINE; VITAMIN C ; VITAMIN D; ZINC
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White