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

Device Problem False Negative Result (1225)

Patient Problems Unspecified Infection (1930); Taste Disorder (4422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

User left a review comment on (b)(6) website on (b)(6) 2022 that the user trusted this test and she/he had strong symptoms unfortunately so tested twice with this kit 24 hrs apart, a week ago.Both came back negative.He/she went back to work when he/she was feeling better but hadn't quite kicked his/her infection.He/she tested with a unknown different brand the day before (on (b)(6) 2022) from this reporting date and came back positive.He/she went in for pcr test this am, will have results back within 72 hrs but he/she have definitely lost their ability to taste/smell.He/she took another of this test an hour ago, still came back negative.Therefore, the user commented that he/she doesn't trust this test at all and he/she could not find any research link or information regarding this test's positive/negative accuracy stats advertised here.Importer comments: event though, only information that opposite test result from (b)(6) kit and different brand kit exists, this complaint can be a suspected false negative result and due to the system functionality to not allow seller can leave the comments on the website, it is not able for us to follow up to collect additional information, such as product information (lot #, expiration date ect) and any evidence of pcr result to prove false result etc following by reporter's consent.

Event Description

User left a review comment on (b)(6) website on (b)(6) 2022 that the user trusted this test and she/he had strong symptoms unfortunately so tested twice with this kit 24 hrs apart, a week ago.Both came back negative.He/she went back to work when he/she was feeling better but hadn't quite kicked his/her infection.He/she tested with a unknown different brand the day before (on (b)(6) 2022) from this reporting date and came back positive.He/she went in for pcr test this am, will have results back within 72 hrs but he/she have definitely lost their ability to taste/smell.He/she took another of this test an hour ago, still came back negative.Therefore, the user commented that he/she doesn't trust this test at all and he/she could not find any research link or information regarding this test's positive/negative accuracy stats advertised here.Importer comments: event though, only information that opposite test result from (b)(6) kit and different brand kit exists, this complaint can be a suspected false negative result and due to the system functionality to not allow seller can leave the comments on the website, it is not able for us to follow up to collect additional information, such as product information (lot #, expiration date ect) and any evidence of pcr result to prove false result etc following by reporter's consent.

• Brand Name: CELLTRION DIATRUST 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: 13560353
• MDR Text Key: 285991806
• Report Number: 3008719759-2022-00048
• 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: Other
• Type of Report: Initial
• Report Date: 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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: 01/27/2022
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1