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

Device Problem False Negative Result (1225)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

On august 4, an amazon customer commented that the product was false result: customer tested all 4 family members along side of abbott's.This (diatrust) one was negative, the abbot one was positive.All 4 times.It even feels flimsily and fake.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, such as product information (lot #, expiration date, etc.) and any evidence of pcr result to prove false result etc following by reporter's consent.

• 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: 15307819
• MDR Text Key: 298775927
• Report Number: 3008719759-2022-00104
• 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: 08/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2022
• 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: 08/04/2022
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1