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

Lot Number 3657170

Device Problem False Positive Result (1227)

Patient Problem Cough (4457)

Event Date 12/15/2021

Event Type  malfunction  

Event Description

Unnecessary quarantine; used the quickvue at home otc covid-19 test kit to rule out covid due to congestion/runny nose/cough for 2 days.Ref.(b)(4), lot 3657170, exp: 2023/10/13.On (b)(6) 2021 rapid test kit was positive after using it correctly, on (b)(6) 2021 obtained pcr at urgent care which resulted negative.Repeated rapid home test kit on (b)(6) 2021 which was positive again.Sought another pcr and rapid antigen test on (b)(6) 2021 at an urgent care which resulted negative.Fda safety report id# (b)(4).

• Brand Name: QUICKVUE AT HOME OTC COVID 19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 13076808
• MDR Text Key: 282815582
• Report Number: MW5106239
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/13/2023
• Device Lot Number: 3657170
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian