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 Headache (1880); Viral Infection (2248); Sore Throat (2396); Lethargy (2560); Cough (4457); Alteration in Body Temperature (4568)

Event Date 04/12/2022

Event Type  malfunction  

Event Description

Customer reported a false negative result on (b)(6) 2022 using the cue covid-19 test for home and over the counter (otc) use cartridge sn (b)(4), lot 21796c, reader sn (b)(4).It is unknown whether the customer was reporting on behalf of a patient or self-reporting.It is unknown if the initial reporter was a healthcare professional.After the false negative event, the individual tested positive with three binaxnow covid-19 tests and three ihealth covid-19 tests; dates are unknown.The individual was symptomatic with a headache, runny nose, congestion, sore throat, cough, lethargy, and elevated temperature (borderline fever).

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 negative test and a member of the technical support group was able to perform data analysis.Investigation summary: the complaint history was reviewed and there were two similar complaints 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.

Manufacturer Narrative

1.Correction to b5 describe event or problem: customer reported a false negative result on (b)(6) 2022 using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(6), lot 21796c, reader sn (b)(6).After the false negative event, the individual tested positive with three binaxnow covid-19 tests and three ihealth covid-19 tests; dates are unknown.The individual was symptomatic with a headache, runny nose, congestion, sore throat, cough, lethargy, and elevated temperature (borderline fever).2.Correction to d1 brand name: cue covid-19 test for home and over the counter (otc) use.3.Correction to d4 model number: c2020.4.Correction to g3/g4 pma/510(k)number: (b)(4).

Event Description

Customer reported a false negative result on (b)(6)2022 using the cue covid-19 test for home and over the counter (otc) use (cartridge sn (b)(6), lot 21796c, reader sn (b)(6).After the false negative event, the individual tested positive with three binaxnow covid-19 tests and three ihealth covid-19 tests; dates are unknown.The individual was symptomatic with a headache, runny nose, congestion, sore throat, cough, lethargy, and elevated temperature (borderline fever).

• 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: 16242611
• MDR Text Key: 308626424
• Report Number: 3016758165-2023-00147
• 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: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/24/2022
• Device Model Number: C2020
• Device Lot Number: 21796C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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