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

Lot Number COVSD1003

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 01/10/2022

Event Type  malfunction  

Event Description

When the user opened two test kits on (b)(6) 2022.Followed preparation instructions on app and instruction sheet.Could not get response with qr code.Manually entered test device serial numbers as follows: (b)(4).Received messages on both (b)(6) devices used: expiration date (b)(6) 2022.This is not a valid diatrust covid-19 ag home test.The user continued the test procedure according to the printed instruction sheet within the specified time, including placing the drops in the test device.The test results were negative, with a red colored line appearing in the c line level 1-11.Expiration date on the outer box is 2022.11.26.Lot number covsd1003.Ref ct-p60 d-2 05.Test tube (extraction buffer) and filter cap: lot covsd1003.Expiration 2022.11.26.Test devices 2 each: lot covsd1003.Expiration 2022.11.26.Specimen collection swabs 2 each: ref fanab01.Lot 10972.Expiration 2024-09.Please advise if the test package is valid.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.

• 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: 13418429
• MDR Text Key: 286767186
• Report Number: 3008719759-2022-00010
• 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: Other
• Type of Report: Initial
• Report Date: 01/21/2022,01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/26/2022
• Device Lot Number: COVSD1003
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/10/2022
• Event Location: Home
• Date Report to Manufacturer: 01/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1