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

Catalog Number 95677

Device Problems False Negative Result (1225); Product Quality Problem (1506)

Patient Problem Viral Infection (2248)

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Maximbio cleardetect covid tests do not work - no control lines when testing on 4 tests.At least one false negative on additional test.Fda safety report id# (b)(4).

• Brand Name: MAXIMBIO CLEARDETECT COVID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): MAXIM BIOMEDICAL INC.
• MDR Report Key: 15825574
• MDR Text Key: 304003821
• Report Number: MW5113346
• Device Sequence Number: 2
• 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: 11/16/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 95677
• Device Lot Number: MB07JUL2201
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2022
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White