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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

Customer reports half of their 40 employees were receiving suspected false positive results when testing with the cue covid-19 test.Review of covid case tracker shows 26 employees who experienced positive results when testing with the cue covid-19 test, while testing negative with alternate covid-19 tests.See related cases for alternate false positive results.Individual 3: individual receiving a potential false positive result on (b)(6) 2022 when testing with the cue covid-19 test (lot 21006c, sn (b)(4).Individual obtained negative results when testing on (b)(6) 2022 with the binaxnow covid-19 and quickvue antigen tests, and on (b)(6) 2022 when testing with the binaxnow covid-19 antigen test.Individual experienced symptoms between (b)(6) 2022 to (b)(6) 20222.Individual experienced mild sore throat and weird taste on (b)(6) 2022.Individual attended in-person events, but did not specify any known exposures.

Manufacturer Narrative

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 test 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: 16026890
• MDR Text Key: 308530142
• Report Number: 3016758165-2022-00582
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/07/2022
• Device Model Number: C2020
• Device Lot Number: 21006C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2021
• 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