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

It was reported that "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.I'm just showing this as this can be quite misleading.".

Manufacturer Narrative

The patient underwent sars-cov-2 antigen test on (b)(6) 2021, and the feedback was "when using the lepu sars-cov-2 antigen test, a super faint line was noticed.However, the hotgen test conducted the next day came back negative, so i'm not sure if the product gave the wrong test result, which could be very misleading." after receiving the above feedback information, the leadership of our company attached great importance to it and immediately organized relevant personnel to conduct an investigation and analysis.According to the feedback information, we know that this product problem report is from hungary.Our products sold in the eu market are registered as required, check the ce certification, the scope of the certificate does not cover reagent testing products, and the company has not submitted an application for registration of such products to the certification body.After investigation, the sars-cov-2 antigen detection product in this case report was not produced by our company.

• 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, 10220 0; CH 102200
• Manufacturer (Section G): LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD; no.37 chaoqian rd.; changping district; beijing, 10220 0; CH 102200
• Manufacturer Contact: bo jiang ; no.37 chaoqian rd.; changping district; beijing, 10220-0 ; CH 102200
• MDR Report Key: 18137841
• MDR Text Key: 328128077
• Report Number: 3008002401-2023-00001
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• 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
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/15/2023
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 56 KG