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U.S. Department of Health and Human Services

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

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QUIDEL CORPORATION QUICKVUE AT HOME COVID 19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM Back to Search Results
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).
 
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Brand NameQUICKVUE AT HOME COVID 19 TEST
Type of DeviceCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
Manufacturer (Section D)
QUIDEL CORPORATION
MDR Report Key13306864
MDR Text Key284194148
Report NumberMW5106805
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 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 Received01/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberF40048
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 01/19/2022 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
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