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

Device Problems False Positive Result (1227); Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2023

Event Type  malfunction  

Event Description

On february 8, an amazon customer commented the product was false positive.A customer got suspicious when they repeatedly tested positive for these products, and were negative on every other brand, including an unknown otc pcr test.So the user put the liquid without sample into the test cassette and it returned a positive! importer comments: due to the system functionality to not allow seller can leave the comments on the website or contact the reporter, it is not able for us to follow up to collect additional information and such as product information (lot #, expiration date, etc.) following by reporter's consent.

Event Description

On february 8, an amazon customer commented the product was false positive.A customer got suspicious when they repeatedly tested positive for these products, and were negative on every other brand, including an unknown otc pcr test.So the user put the liquid without sample into the test cassette and it returned a positive! importer comments: due to the system functionality to not allow seller can leave the comments on the website or contact the reporter, it is not able for us to follow up to collect additional information and such as product information (lot #, expiration date, etc.) following by reporter's consent.Follow-up 1: on february 14, celltrion first reported it as 3008719759-2023-00021.On february 11th, this user also reported this incident directly to the medwatch 3500a to the fda (mdr# mw5114929) and the fda forwarded it to nephron pharmaceuticals, listed as the manufacturer in mw5114929.On february 17, nephron received an email with mw5114929 attached from fda, determined that the report was a celltrion product, and informed celltrion by forwarding the the fda email with mw5114929 on the same day.Celltrion confirmed that the already reported 3008719759-2023-00021 was the same case as mw5114929 through a follow-up to the initial reporter.However, because the user discarded the product before becoming aware of the false positive, the reporter could not provide product details such as batch number, and therefore celltrion would like to inform the fda that it is no longer able to investigate the product.We will update this follow-up mdr to the manufacturer for reference.Please refer to the attached medwatch (mw5114929).

• Brand Name: DIATRUSTTM 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: 16372413
• MDR Text Key: 309494484
• Report Number: 3008719759-2023-00021
• 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,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/17/2023
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1