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

Lot Number COVGCA 1005

Device Problem False Negative Result (1225)

Patient Problems Viral Infection (2248); Insufficient Information (4580)

Event Date 09/14/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, fda issued a medwatch letter to manufacturer and celltrion usa, inc.Due to a voluntary spontaneous report (mw5112071) for celltrion diatrust covid ag rapid test.This letter was received on oct 07 via courier.The consumer said that the product was false negative at 15 minutes and detected faint positive result after 1 hour, despite the instructions describing a detection time of 15 minutes.Subsequent patients have tested positive on home testing devices, the results were negative on celltrion diatrust kit, the sample was retested on alternate covid-19 antigent kit (allere binax now) and positive results obtained as per package insert.Fda safety report id# (b)(4).And the initial reporter has assigned 'healteh-effect-clinical code(s)' as 2248 (viral infection) in the section "device manufacturer only".Importer comments: as initial reporter's consent to follow up by importer it is not able for us to follow up to confirm any evidence of pcr result to prove false result etc.

• Brand Name: DIATRUSTTM COVID-19 AG RAPID 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: 15626009
• MDR Text Key: 301947833
• Report Number: 3008719759-2022-00140
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2022,10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: COVGCA 1005
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2022
• Distributor Facility Aware Date: 10/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1