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

Device Problems False Negative Result (1225); False Positive Result (1227); Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

On (b)(6), an amazon customer commented that the product was not accurate.The customer said that these tests do not seem as accurate as others on the market, as both negative and positive test results came from the same test pack.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.Therefore, we don't know which test result was correct between negative and positive.

• 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: 16505546
• MDR Text Key: 310910534
• Report Number: 3008719759-2023-00022
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/24/2023
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1