MAUDE Adverse Event Report: CELTRION DIATRUST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problems Product Quality Problem (1506); Material Too Soft/Flexible (4007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2022

Event Type  malfunction  

Event Description

To visit my stepmother at her nursing home, an antigen-based covid-19 test is administered.Yesterday, the nursing home started using the celltrion diatrust test.The swab is extraordinarily flimsy.It seems nearly impossible to get a good sample using this test.Over the past two+ years, i have had multiple tests from multiple brands administered.Never have i been tested with a swab that is so deficient and seemingly ineffective.I do not believe this is the celltrion diatrust kit that has been recalled by the agency as the container is white, green and purple.Fda safety report id# (b)(4).

• Brand Name: DIATRUST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): CELTRION; 1 evertrust plaza ste 1207; jersey city
• MDR Report Key: 15066756
• MDR Text Key: 296300169
• Report Number: MW5110957
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White