MAUDE Adverse Event Report: CUE HEALTH, INC. CUE COVID-19 TEST CARTRIDGE POUCH/ READER; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Model Number C0201

Device Problems False Positive Result (1227); Product Quality Problem (1506); Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/13/2022

Event Type  Injury  

Event Description

My employer instituted mandatory asymptomatic screening using the cue covid-19 test about a month ago.Mine is s/n (b)(4), cartridge lot 22704l.Over my first 20 tests on the cue the device failed to detect rnase p control in my swab 30% of the time, and i got a pcr verified false positive within the first 10 tests.I have used the test according to the instructions carefully.I previously used rapid tests (binaxnow) daily for about two months with no issues.In the last month, four other people have reported false positives with cue and two people have come to work with symptomatic covid after testing negative by cue tests a couple of times.Since we adopted cue testing, we are no longer required to wear masks and social distance at work, as if they think the cue tests are going to reliably detect asymptomatic and early covid infections due to irresponsible and inaccurate marketing claims by cue.The cue test materials themselves contain legal disclaimers that a negative test for an asymptomatic person is noninformative, and i think my company is putting us at risk by misinterpreting the very slick marketing materials for cue.I went looking for real world cue data, especially technical specifications because i am an assay developer and molecular screening scientist.The data seems very sparse and highly curated in the literature.Many of the scientists in our group are concerned that the device is basically a scam and using it is worse than nothing, but our employer won't admit there is a problem or change course.Fda safety report id# (b)(4).

• Brand Name: CUE COVID-19 TEST CARTRIDGE POUCH/ READER
• Type of Device: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): CUE HEALTH, INC.
• MDR Report Key: 14436381
• MDR Text Key: 292172961
• Report Number: MW5109772
• Device Sequence Number: 1
• Product Code: QJR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/16/2022
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2022
• Device Model Number: C0201
• Device Lot Number: 22704L (CARTRIDGE)
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 40 YR
• Patient Sex: Female