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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Diarrhea (1811); Pain (1994); Sore Throat (2396)

Event Type  Injury  

Event Description

On mar 11, 2022, the reporter sent an email to celltrion customer center (cs) that he requesting the components of the celltrion diatrust covid-19 ag rapid test, and to contact by phone number, because adverse reactions occurred after testing with a nasal swab.However, he did not describe the type of symtom of adverse reactions.Although celltrion received this case on march 11, 2022, the celltrion responsible person was aware of this incident on may 26, 2022, and celltrion cs delivered follow-up receipt information as follows.The reporter was being tested during 17 weeks for his job, mandated testing by hcp.The hospital that was doing the testing was using the celltrion rapid tests & care start tests.He was tested multiple times per week.Symptoms began in late (b)(6) (testing date: (b)(6) 2021 to (b)(6) 2022) in conjunction with testing and subsided soon after testing was completed.Green stoles, diarrhea, throat issues (soar & tight throat), lower right quadrant pain.Importer comments: celltrion is continuing to follow up on this incident identifying lot numbers and expiration dates with consumer consent as hcp did not provide a record, and other additional information may be available.Lot numbers#: cv1960802, cv1968479, cv1969106, cv1969924, cv1970767, cv1971772, cv1972613, cv1974253, cv1975958, cv1977769, cv19091815, cv19093448, cv19095291, cv19096400, cv19099490, cv19100420, and cv19101237.

• Brand Name: CELLTRION DIATRUST COVID-19 AG RAPIDTEST
• 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: 14573156
• MDR Text Key: 293469449
• Report Number: 3008719759-2022-00073
• 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: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2022
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Male