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

Device Problem False Negative Result (1225)

Patient Problem Viral Infection (2248)

Event Date 12/23/2023

Event Type  malfunction  

Event Description

On january 2, 2024, celltrion usa was notified by fda letter of a false negative case (ref.Mw5149627) reported to the us fda through the medwatch reporting system.The user only reported a false negative on (b)(6) 2023 without any detailed description or explanation in the report.Importer comments: celltrion usa is currently acting as an importer and distributor of the 'celltrion diatrust covid-19 diagnostic test kit', which was approved under eua by usfda in 2020.Until now, celltrion has been reported emdrs to the us fda using the manufacturer's fei#, but the fei# was recently changed to invalid.Therefore, celltrion cannot immediately report this mdr until this issue is solved.Accordingly, celltrion will report mdr through a voluntary reporting process instead of a mandatory reporting process to show its commitment to reporting.This report is the initial case reported by the user.If we get receive additional information from the user, we will report to fda.

• Brand Name: DIATRUSTTM 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: 18754005
• MDR Text Key: 335936769
• Report Number: 3015423092-2024-00002
• 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: 12/23/2023,02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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?: Yes
• Date Report Sent to FDA: 12/23/2023
• Distributor Facility Aware Date: 01/01/2024
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1