MAUDE Adverse Event Report: LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD NASOCHECKCOMFORT SARS-COV-2 ANTIGEN-TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.

Device Problem Poor Quality Image (1408)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/18/2021

Event Type  malfunction  

Event Description

I've been taking two types of covid antigen tests in the past couple of days as i have been in contact with covid infected individuals last week.One of them was the: hotgen coronavirus antigentest and the other one was the: lepu medical nasocheck comfort sars-cov- 2 antigen test so far all of them came back negative however last night on the lepu medical test i noticed that there was a super faint line.I however wasn't sure how to interpret this as on the description positive is shown as a distinct red line.The next morning i took the hotgen test which came back negative completely.Therefore, im not sure whether i should be concerned or not as im not sure whether the lepu medical test or the hotgen is the one that is giving false results.Or whether the faint line means anything.Im just showing this as this can be quite misleading.Fda safety report id# (b)(4).

• Brand Name: NASOCHECKCOMFORT SARS-COV-2 ANTIGEN-TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM.
• Manufacturer (Section D): LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD; no.37 chaoqian rd.; changping district ; beijing CN 10 2200; CH CN 102200
• MDR Report Key: 12202294
• MDR Text Key: 262882803
• Report Number: MW5102630
• Device Sequence Number: 1
• Product Code: QKP
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/19/2021

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
• Device Expiration Date: 02/24/2022
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/20/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 56