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 Viral Infection (2248); Sore Throat (2396)

Event Date 05/05/2022

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Customer received two potential false negative results when testing with the cue covid-19 test for home and over the counter (otc) use.This report is to document one of the two false negative results.See case-(b)(4) for alternate false negative result.Customer 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 18785d, reader sn (b)(4)).A cue covid-19 performed on (b)(6) 2022 provided a positive result.On (b)(6) 2022, customer tested positive with two unspecified covid-19 antigen tests.Customer was exposed to covid-19 on (b)(6) 2022 and reported symptoms such as congestion and a sore throat.Customer mentioned the cartridges had been exposed to cold temperatures outside the recommended temperature range overnight in a car around five days before the customer first tested negative.

• 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: 16309341
• MDR Text Key: 308970437
• Report Number: 3016758165-2023-00265
• 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: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/29/2022
• Device Model Number: C2020
• Device Lot Number: 18785D, 19902D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2021
• 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