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

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.

• 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 Key: 16423639
• MDR Text Key: 310270439
• Report Number: 3016758165-2023-00397
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA210180
• Number of Events Reported: 1
• 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 Date: 10/27/2022
• Device Model Number: C2020
• Device Lot Number: 22229A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1