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

Device Problem Computer System Security Problem (2899)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

User left a commented on the (b)(6) website that there was an error occurred when scanning the code.It appeared as not a valid test.Importer comments: this was 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, it is not able for us to follow up to collect additional information, such as product information (lot #, expiration date ect) 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: 13549738
• MDR Text Key: 286767208
• Report Number: 3008719759-2022-00046
• 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: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/11/2022
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1