MAUDE Adverse Event Report: COVID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Fluid/Blood Leak (1250)

Patient Problem Viral Infection (2248)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

Repeated positive covid tests with product.Spilled test solution on countertop.(b)(6).

• Brand Name: COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• MDR Report Key: 16902685
• MDR Text Key: 314986583
• Report Number: MW5117408
• 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: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• 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 Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White