MAUDE Adverse Event Report: HUMASIS CO., LTD. CELLTRION DIATRUST COVID-19 AG HOME TEST; IN VITRO DIAGNOSTICS

Model Number CT-P60 D-2 05

Device Problems False Negative Result (1225); Computer System Security Problem (2899)

Patient Problem Viral Infection (2248)

Event Type  malfunction  

Event Description

On march 8, 2022, a user reported product complaints about the product to amazon customer service center, and the staff sent an email to celltrion.Asin : b09m7gkccb, upc : 8806121763235, model # :ct-p60 d-2 05.User said that all four tests came back negative despite a rapid antigen test being positive at urgent care.Unfortunately, she trusted this test and she had strong symptoms, and she tested twice with this kit 24 hrs apart, a week ago.Both came back negative.When she felt better she started working again but hadn't quite kicked the infection.She tested with a different brand yesterday and came back positive.When she scanned the test device's qr code as per instructions, it said "problem serial number" this is not a valid covid-19 ag home test did 2 tests and both negative.2nd test was done same day as pcr which came back positive.Importer comments: this is a phenomenon that occurs because the serial number of the product and the application for activation are not synchronized.There is no error with the diagnosis of covid-19 but activation of the application through qr code is part of the product's functionality so that we assessed this is in criteria of 'malfunction' according to the 21cfr803.Due to the system functionality to not allow seller can leave the comments on the website or contact the reporter, it is not able for us to follow up to collect additional information, such as product information (lot #, expiration date etc.) and any further information to investigate the type of complaint following by reporter's consent.

• Brand Name: CELLTRION DIATRUST COVID-19 AG HOME TEST
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): HUMASIS CO., LTD.; 88, jeonpa-ro; dongan-gu; anyang-si, gyeonggi-do 14042 ; KS 14042
• MDR Report Key: 13906027
• MDR Text Key: 295250307
• Report Number: 3008719759-2022-00055
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CT-P60 D-2 05
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/08/2022
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female