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

Device Problem False Positive Result (1227)

Patient Problem Emotional Changes (1831)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

I took 3 quidel at home covid tests on (b)(6) and (b)(6) which all showed faint positive results after i had a stomach bug and fever the previous day.My entire family had to quarantine due to thinking i had covid.I got a pcr test on (b)(6) and did not receive results until (b)(6) that the test was negative.I had to stay home the whole week from work, using my own sick leave and keep my kids joke from school while still having to pay their daycare costs out of pocket.We had to miss all extracurricular activities.I was emotionally distraught waiting on pcr test results.The rest of the family tested negative and their pcr results came back much faster.This false positive from this brand of at home test negatively impacted my finances, mental health, and entire family.I took a binax at home test on (b)(6) and (b)(6) while waiting for my results which both showed negative.I believe this brand should be researched for false positive results.I am embarrassed and i can't get the time back from work or school for the kids.This was the same result of 3 tests taken over 2 days.My husband took the 4th test we had and his was negative.Covid test due to symptoms.

• Brand Name: QUIDEL QUICKVUE AT HOME OTC COVID-19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORP.
• MDR Report Key: 13011723
• MDR Text Key: 282397008
• Report Number: MW5106058
• Device Sequence Number: 3
• 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: 12/12/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Treatment: DAILY VITAMIN
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White