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

Device Problem False Negative Result (1225)

Patient Problem Cough (4457)

Event Type  Injury  

Event Description

On (b)(6), an amazon customer commented that the product was false negative.Before traveling to amsterdam in late (b)(6), the user tested himself using the kit as he began experiencing sinus problems similar to those he experienced when he/she first contracted coronavirus a few months ago.His/her test result was negative, so he/she thought everything was ok, and he/she brought the test kit with him/her on the trip, as is standard travel practice when you feel you need to get tested.A few days after the trip, the symptoms started to get worse, so he/she took the test again and it was still negative.When he returned home about four days later, he/she said he was miserable, with severe congestion and severe coughing.(the user said he/she brought a mask and wore it in public when he started coughing to alleviate other people getting sick, and that it wasn't covid).The user took the test immediately upon returning and the result was negative.The day after his/her return, the user thought he/she might have pneumonia and went to the emergency room to get a pcr test, which surprisingly told me that what he/she was suffering from was actually covid.The consumer said he/she would never purchase this product again and would not recommend it to anyone else.Users noted that not only were they wasting money, but they were putting their own health and the health of others at risk by not treating their symptoms as covid-19 and not following safer practices to alleviate them in public.From now on, consumers will save money by taking a pcr test if they think they may have covid and treating allergy/cold symptoms similar to the protocols they would use if they had covid to boost their immunity.Importer comments: this report is the second of three cases in this spontaneous report by user.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.

• 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: 17712578
• MDR Text Key: 322982641
• Report Number: 3008719759-2023-00056
• 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: 09/08/2023

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 Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2023
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male