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

Lot Number COVSD1003

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2022

Event Type  malfunction  

Event Description

The pharmacist bought these tests and have gotten multiple complains about the qr code not working correctly.The pharmacist's customers state that when scanning the code they get a message saying that these are not valid tests and that they are expired.The pharmacist have had to refund a few people because of this matter.The pharmacist asked to get an answer for the customers who are coming back worried they have paid for an item that doesn't work.Importer comments: this is a phenomenon that occurs because the serial number of the product and the application for activation are not synchronized.There is no error with the diagnosis of covid-19 but activation of the application through qr code is part of the product's functionality so that we assessed this is in criteria of "malfunction" according to the 21cfr803.

• 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: 13418492
• MDR Text Key: 286767497
• Report Number: 3008719759-2022-00013
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 01/21/2022,01/25/2022

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: Lay User/Patient
• Device Expiration Date: 11/26/2022
• Device Lot Number: COVSD1003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/08/2022
• Event Location: Home
• Date Report to Manufacturer: 01/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1