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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CUE HEALTH INC. CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

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CUE HEALTH INC. CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID Back to Search Results
Model Number C2020
Device Problem False Negative Result (1225)
Patient Problems Viral Infection (2248); Sore Throat (2396)
Event Date 02/12/2023
Event Type  malfunction  
Manufacturer Narrative
Response to device evaluated by manufacturer: cartridges used by the consumer were not sent back for evaluation, therefore, the devices could not be evaluated.The customer provided information regarding the suspected false negative test and a member of the technical support group was able to perform data analysis.Investigation summary: the complaint history was reviewed and there were no previous similar complaints against involved lot.The lot history record (lhr) was reviewed for the lot number in the complaint, and it passed release specifications.A technical support representative reviewed customer data and performed data analysis.All data values were normal and met acceptable criteria.Root cause was undetermined.
 
Event Description
Customer received a false negative result on (b)(6) 2023 using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4), lot 26499b, reader sn (b)(4) ).The same day, the customer tested positive two times with binaxnow covid-19 ag card tests and once with an unknown covid-19 antigen test.Repeat cue covid-19 test performed on (b)(6) 2023 provided a positive result.Customer reported sore throat, no known exposure, and confirmed the cartridges were stored according to the instructions for use (70 degrees f).
 
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Brand Name
CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE
Type of Device
REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
Manufacturer (Section D)
CUE HEALTH INC.
4980 carroll canyon rd.
suite 100
san diego CA 92121
Manufacturer Contact
roderick castillo
4980 carroll canyon rd.
suite 100
san diego, CA 92121
8332838378
MDR Report Key16448526
MDR Text Key310855699
Report Number3016758165-2023-00415
Device Sequence Number1
Product Code QJR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EUA210180
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/27/2023
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 Operator Lay User/Patient
Device Expiration Date06/06/2023
Device Model NumberC2020
Device Lot Number26499B
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/12/2023
Initial Date FDA Received02/27/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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