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); Unspecified Respiratory Problem (4464)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

Customer reports false negative results when testing three individuals with the cue covid-19 test for home and over the counter (otc) use.This report is to document one of the false negative results for individual 1.See related cases for alternate false negative results.Individual received a 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 24485d, reader sn (b)(4)).Individual tested positive with the following tests: (b)(6) 2022: sars-cov-2 pcr test - positive result.(b)(6) 2022: ihealth rapid antigen test - positive result.(b)(6) 2022: ihealth rapid antigen test - positive result.(b)(6) 2022: ihealth rapid antigen test - positive result.(b)(6) 2022: ihealth rapid antigen test - positive result.(b)(6) 2022: ihealth rapid antigen test - positive result.(b)(6) 2022: ihealth rapid antigen test - positive result.(b)(6) 2022: ihealth rapid antigen test - positive result.Individual began experiencing symptoms of congestion and fatigue on (b)(6) 2022 and had exposure to daughter who began showing symptoms on (b)(6) 2022.Cartridges were stored within the validated temperature range.

Manufacturer Narrative

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 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.Technical operations reproduced the failure mode of false negatives during investigation.From the investigation, the cartridges that generated false negative tests revealed no significant mechanical failures or contributions to the false negative results.Subsequent investigation into the wet reagent buffers and the pellet similarly found inconclusive results.Additional root cause analysis was unable to determine a true root cause for the failures in this cartridge lot.The root cause is 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: 16406246
• MDR Text Key: 310247672
• Report Number: 3016758165-2023-00354
• 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: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/11/2023
• Device Model Number: C2020
• Device Lot Number: 24485D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/11/2022
• 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