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

Lot Number F40048

Device Problem False Positive Result (1227)

Patient Problems Fever (1858); Hypothermia (1915); Hypoxia (1918); Pneumonia (2011); Sepsis (2067); Urinary Tract Infection (2120); Cognitive Changes (2551); Renal Impairment (4499)

Event Date 01/12/2022

Event Type  Injury  

Event Description

My mother is (b)(6) and has chosen to not be vaccinated for covid even though the rest of the household is vaccinated and boosted.On (b)(6) 2022 she developed a fever and tested positive for covid using a quickvue at home brand test kit.(photo of strip showing the positive matches the photo on the box) my sister used the second test in the kit and was negative.Due to the covid positive result we were monitoring her at home and did not seek treatment for her ongoing fever.On (b)(6) 2022 and (b)(6) 2022 her fever seemed to be resolving, but she was becoming mentally altered and eventually hypothermia and hypoxic.She was taken to the er and given a rapid antigen and pcr test and both were negative.They diagnosed a uti which had progressed to sepsis and secondary acute kidney injury due to hypoxia.She has been hospitalized for the past 5 days.She also has congestive heart failure which has been well regulated and her ejection fraction on echo in (b)(6) 2021 was over 50%.On presentation to er she was decompensating with the ef dropping too.As her azotemia has been worsening, her sodium has been falling.Her wbc improved initially, bit has increase to the same level as she was at presentation, in spite of the antibiotic therapy.Initial radiographs and ct obtained on (b)(6) 2022 did not show pneumonia, but follow up images from (b)(6) 2022 show some pneumonia.Fda safety report id# (b)(4).

• Brand Name: QUICKVUE AT HOME COVID 19 TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): QUIDEL CORPORATION
• MDR Report Key: 13306864
• MDR Text Key: 284194148
• Report Number: MW5106805
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/05/2023
• Device Lot Number: F40048
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADVIL PRN (1 TAB AS NEEDED FOR BACK PAIN); B-COMPLEX; CARVEDILOL ; LEFLUNOMIDE; MULTI-VITAMIN; QUINAPRIL ; VITAMIN C; VITAMIN D
• Patient Outcome(s): Life Threatening; Disability; Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White