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

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2022

Event Type  malfunction  

Event Description

On may 26, 2022, fda issued a medwatch letter to manufacturer and *=(b)(4) due to a voluntary spontaneous report (mw5109836) for celltrion diatrust covid ag home test.The consumer has purchased the products on the website of amazon and had some problems with the function of app.And the initial reporter has assigned (b)(4).The initial reporter reported to fda via medwatch as below: "i tried to use the celltrion diatrust covid-19 ag home test.Following all instruction, both by computer and by smartphone app, neither worked.On the website i tired in the test's serial number and was told it was invalid.Twice.The typing was correct.Using the phone app, i attempted to scan the qr code.The screen went blank.I tried twice.I obtained two boxes of celltrion tests on amazon.I was exposed to covid first on (b)(6) 2022.My last exposure in that household was (b)(6).During that period, i was negative on one pcr test and at least 5 home tests of another brand.I also tested negative on (b)(6).The celltrion test is clearly defective.I followed all instruction, as i did on previous test on another brand (which i don't remember).I will return the tests to (b)(6).The laboratory data request is not applicable.Fda safety report ic# (b)(4)." 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.

• Brand Name: CELLTRION DIATRUST COVID-19 AG HOMETEST
• 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: 14684531
• MDR Text Key: 294896878
• Report Number: 3008719759-2022-00079
• 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: 05/20/2022,06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2022
• Distributor Facility Aware Date: 05/26/2022
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1