MAUDE Adverse Event Report: SD BIOSENSOR, INC. COVID-19 AT-HOME TEST PILOT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number 53K38N5T1

Device Problem Microbial Contamination of Device (2303)

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

Event Type  malfunction  

Event Description

We received a letter from the fda advising us to throw away our tests because of a bacteria contaminated covid 19 pilot test.We were told to also contact you for further directions.

• Brand Name: COVID-19 AT-HOME TEST PILOT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): SD BIOSENSOR, INC.
• MDR Report Key: 17019747
• MDR Text Key: 316206084
• Report Number: MW5117944
• 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: Patient
• Type of Report: Initial
• Report Date: 05/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/16/2023
• Device Lot Number: 53K38N5T1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2023
• Patient Sequence Number: 1