MAUDE Adverse Event Report: HUMASIS INC. / CELLTRION USA, INC. CELLTRION DIATRUST COVID-19 AG HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Patient Problem Viral Infection (2248)

Event Date 12/22/2023

Event Type  malfunction  

Event Description

On december 22, 2023, celltrion usa received an email with complaint of false negative.The user emailed that the covid test with diatrust was false negative because the user tested positive at the dr office.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.[user information: name: (b)(6)].

• Brand Name: CELLTRION DIATRUST COVID-19 AG HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): HUMASIS INC. / CELLTRION USA, INC.; one evertrust plaza, suite 1207; jersey city NJ 07302
• MDR Report Key: 18552017
• MDR Text Key: 333473004
• Report Number: MW5150578
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: KN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1