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

Device Problems Labelling, Instructions for Use or Training Problem (1318); Computer System Security Problem (2899)

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

Event Type  malfunction  

Event Description

On (b)(6) 2022, a user left a review comment on the (b)(6) website stating that the instructions in the printed manual were skimpy and the paper manual was not good as the qr code for video instruction linked directly to social media app installation.And with video support, it can be downloaded social media app, the installation of which the user think don't need at all.He/she felt that the point of home test kits is to determine whether there is a problem at home or in privacy.The user think that social media intrusion should not be part of the deal.The user followed the instructions, but the first test was not valid and the second test was not.Users said that test kits from other manufacturers he/she has used before gave much better instructions and didn't require downloading any kind of app.Importer comments: this complaint is quite uncertain to determine of the complaint but based on user's review comments, it is suspected 'invalidity' of app which might the application for activation is not valid.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) 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: 13586566
• MDR Text Key: 286514517
• Report Number: 3008719759-2022-00053
• 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: 02/22/2022

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/14/2022
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1