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 CUE COVID-19 TEST CARTRIDGE PACK, HOME & OTC, 10-PK (C2020)

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 02/18/2023

Event Type  malfunction  

Event Description

Customer reports false negative results for two family members when testing with the cue covid-19 test for home and over the counter (otc) use.This report is to document the false negative result for individual 1.See related case for alternate false negative result.Individual received a false negative result on (b)(6) 2023 when using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4), lot 25104g, reader sn (b)(4)).Individual tested positive on (b)(6) 2023 with an unspecified covid-19 at-home antigen test.Individual experienced symptoms at the time of testing.

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 test and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there was one previous 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.

Manufacturer Narrative

Correction to h10: 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.

• 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: 16456316
• MDR Text Key: 310412062
• Report Number: 3016758165-2023-00432
• 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,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/08/2023
• Device Model Number: CUE COVID-19 TEST CARTRIDGE PACK, HOME & OTC, 10-PK (C2020)
• Device Lot Number: 25104G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• 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