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 Fever (1858); Headache (1880); Muscle Weakness (1967)

Event Date 11/28/2022

Event Type  malfunction  

Event Description

Customer reports receiving one false positive result and one false negative result when testing with the cue covid-19 test for home and over the counter (otc) use.This mdr is to document the false negative result.See (b)(4) for the false positive result.Customer also reports daughter obtained a false negative result when testing with the cue covid-19 test for home and over the counter (otc) use.See (b)(4) for daughter's false negative result.On (b)(6) 2022, customer received a false negative result using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4), lot 24022b, reader sn (b)(4)).A repeat cue test performed on the same day provided a positive result.No alternate confirmatory testing performed, but suspects this is a false negative due to symptoms.Customer reported they developed symptoms (weakness, aches, then a fever) about 4 days after they spent ~18 hours straight unmasked (and often in small spaces, e.G.The same car) with someone who was symptomatic and tested positive with a pcr test.During those 4 days, customer had a fever for 2-3 days, hitting a high of 104 f/40 c.Cartridge's were stored properly per instructions for use.

Manufacturer Narrative

The investigation is still in process.Findings and the conclusion will be provided in a supplemental report after the investigation has been concluded.

Manufacturer Narrative

Investigation conclusion: explanation for h3: 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.

• 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: 16018165
• MDR Text Key: 308547965
• Report Number: 3016758165-2022-00577
• 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: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/21/2022
• Device Model Number: C2020
• Device Lot Number: 24022B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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