MAUDE Adverse Event Report: ACCESS BIO INCORPORATE CARESTART COVID-19 ANTIGEN HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number CP22J03

Patient Problem Insufficient Information (4580)

Event Date 12/24/2023

Event Type  malfunction  

Event Description

Test fluid did not properly absorb and migrate through test cartridge.Invalid result obtained on 3 different test cartridges.Lot: cp22j03.Reference reports: mw5149606, mw5149607.

• Brand Name: CARESTART COVID-19 ANTIGEN HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACCESS BIO INCORPORATE
• MDR Report Key: 18409079
• MDR Text Key: 331545393
• Report Number: MW5149605
• Device Sequence Number: 1
• 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: 12/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: CP22J03
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose