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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 Fatigue (1849); Viral Infection (2248); Cough (4457)
Event Date 06/03/2022
Event Type  malfunction  
Event Description
Customer reported false negative results for two individuals using the cue covid-19 test for home and over the counter (otc) use.This mdr is to document the false negative result for individual 1.See related cases for the additional false negative results.Individual received suspected false negative result on (b)(6) 2022 using the cue covid-19 test for home and over the counter (otc) use cartridge sn (b)(4), lot 22229a, reader sn (b)(4).Individual obtained the following results on alternate tests: (b)(6) 2022: ihealth antigen test - negative result.(b)(6) 2022: ihealth antigen test - negative result.(b)(6) 2022: sars-cov-2 pcr test @ kaiser - negative result.(b)(6) 2022: quickvue at-home otc covid-19 test - positive result.(b)(6) 2022: quickvue at-home otc covid-19 test - positive result.(b)(6) 2022: ihealth antigen test - negative result.(b)(6) 2022: quickvue at-home otc covid-19 test - positive result.(b)(6) 2022: quickvue at-home otc covid-19 test - positive result.(b)(6) 2022: cue covid-19 test - positive result.Individual had cough/cold symptoms (congestion, running nose, fatigue) beginning 29-may-2022 and had attended an outside wedding the weekend before where masks were not worn.
 
Manufacturer Narrative
Explanation for device evaluated by mfr: 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 tests and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there was one similar complaint 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.
 
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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 Key16423639
MDR Text Key310270439
Report Number3016758165-2023-00397
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 02/22/2023
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 Date10/27/2022
Device Model NumberC2020
Device Lot Number22229A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/11/2022
Initial Date FDA Received02/22/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/27/2022
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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