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 Dyspnea (1816); Viral Infection (2248)

Event Type  malfunction  

Event Description

The fda medical device reporting team provided report mw5110303 that was received through fda¿s medwatch program.The fda redacted the dates in the description of the event.Mw5110303 reports four false negative results for two individuals when testing with the cue covid-19 test for home and over the counter (otc) use.This report is to document one of the three false negative results obtained for individual 1.See related cases for alternate false negative results.Individual 1: customer reports receiving a suspected false negative result on an unknown date when testing with the cue covid-19 test for home and over the counter (otc) use (cartridge sn, lot number, reader sn not provided).Customer showed visible and obvious symptoms of covid-19 after initial false negative result.Customer tested positive on an unknown date with an unknown methodology.Customer reports worsening symptoms including breathing problems.Customer was prescribed antivirals on an unknown date.

Manufacturer Narrative

Cartridges used by the consumer were not sent back for evaluation, therefore, the devices could not be evaluated.The customer provided limited information regarding the suspected false negative tests.Investigation could not be completed due to lack of information.Lot number, reader serial number or cartridge serial number were not provided.

• 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: 16229574
• MDR Text Key: 308129543
• Report Number: 3016758165-2023-00121
• 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: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: C2020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: No
• 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