MAUDE Adverse Event Report: MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 95677

Device Problems Product Quality Problem (1506); Missing Test Results (3267)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

Covid test strips not producing any result.Control line not appearing, despite scrupulously following instructions.Two tests in same box produced same non-result.

• Brand Name: CLEARDETECT COVID-19 ANTIGEN HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): MAXIMBIO
• MDR Report Key: 15986915
• MDR Text Key: 305527775
• Report Number: MW5113787
• 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: 12/12/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/26/2022
• Device Model Number: 95677
• Device Lot Number: MB11MAY2201
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2022
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White