MAUDE Adverse Event Report: MAXIM BIOMEDICAL, INC. CLEARDETECT COVID-19 ANTIGEN TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number 87506

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/14/2022

Event Type  malfunction  

Event Description

Two faulty at-home covid tests.No results from two test strips.Two test strips gave no result.Lot#k0420, ref#87506.Fda safety report id# (b)(4).

• Brand Name: CLEARDETECT COVID-19 ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): MAXIM BIOMEDICAL, INC.; 1500 east gude drive; ste a; rockville MD 20850
• MDR Report Key: 15241062
• MDR Text Key: 298203210
• Report Number: MW5111498
• Device Sequence Number: 2
• Product Code: QKP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/14/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 87506
• Device Lot Number: K0420
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Male