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

Lot Number COVGCB1003

Device Problem Display Difficult to Read (1181)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The initial reporter in health care service center reported product complaints from his/her experiences with the celltrion diatrust covid-19 ag rapid test on (b)(6) 2022 via email.The issue is with the lot # covgcb1003 exp date: 11/4/2022.It was said the positive control is almost too faint to read or does not show up and it was reported from several of their clinics on this lot number that he/she has received in the last few days.The reporter said he/she has other reports that the lines are very faint and it is taking 13-15 minutes for the positive line to appear.The reporter asked us to check if this is an issue with this lot number.The reporter said he/she has also contacted his/her distributor with this issue and this is the first time the reporter have had this issue reported to him/her and he/she have used this test for several months.Importer comment: importer responded to reporter that due to reading test before 15 minutes or after 20 minutes, sometimes false positive or negative result identified and acknowledged this complaint is about having faint line or missing line in positive control.We also asked more details to the reporter such as affected quantity, number of customers(or clinics), name of distributor etc and received the information that he/she have had two different clinics that had issues with this lot number and the positive control (at least 2 boxes) it is the first time we receive this type of complaints regarding the batch # covgcb1003.

• Brand Name: CELLTRION DIATRUST COVID-19 AG RAPID 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: 13906042
• MDR Text Key: 295251772
• Report Number: 3008719759-2022-00057
• 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: 03/24/2022

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: Health Professional
• Device Expiration Date: 11/04/2022
• Device Lot Number: COVGCB1003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2022
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1