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 Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 02/06/2023

Event Type  malfunction  

Manufacturer Narrative

Response to 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 positive tests and a member of the technical support group was able to perform data analysis.The complaint history was reviewed and there were three 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.Technical operations performed retain testing and was unable to confirm the customer complaint.No false positive results were observed.A technical support representative reviewed customer data and performed data analysis.Root cause was undetermined.

Event Description

Customer reports false positive results for five individuals when testing with the cue covid-19 test for home and over the counter (otc) use.This report is to document the false positive result for individual 4.See related cases for alternate false positive results.Individual received a false positive 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 27520a, reader sn (b)(4)).No additional information was provided regarding this false positive event.

• 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: 16457205
• MDR Text Key: 310412705
• Report Number: 3016758165-2023-00430
• 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: 02/28/2023

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: 07/20/2023
• Device Model Number: C2020
• Device Lot Number: 27520A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2022
• 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