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 Problems Sneezing (2251); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/06/2022

Event Type  malfunction  

Event Description

Customer reporting on behalf of relative (daughter).Customer reported an individual received a false positive result on (b)(6) 2022 using cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(4) followed by a negative result (cartridge sn (b)(4) on cue reader sn (b)(4) with cartridge lot 20857e on the same day.Customer reported the individual's sars-cov-2 pcr test, by color health, was negative on (b)(6) 2022.The non-vaccinated individual was in close contact with exposure on (b)(6) 2022.The individual presented with symptoms (runny nose and occasional sneezing).Customer confirmed cartridges were stored in the appropriate temperature range per package insert.

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 positive 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: 15664116
• MDR Text Key: 306708239
• Report Number: 3016758165-2022-00180
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• 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: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/14/2022
• Device Model Number: C2020
• Device Lot Number: 20857E
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/08/2022
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/14/2021
• 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