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

Lot Number 53K38N5T1

Device Problems False Positive Result (1227); Nonstandard Device (1420)

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

Event Date 04/21/2023

Event Type  malfunction  

Event Description

False positives on recalled pilot covid antigen self-tests.This happened with 3 tests in lot 53k38n5t1 (which is now part of the recall).My husband and i got a very faint positive.We were testing because we had been potentially exposed to someone later diagnosed with covid.We had no symptoms at all.We both tested again with a different brand and were negative.My husband who had greater exposure got a pcr test to make sure he was negative and he was.We had no illness as a result of using the pilot tests.Reference reports: mw5117529, mw5117531.

• Brand Name: PILOT COVID 19 ANTIGEN TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): SD BIOSENSOR, INC.
• MDR Report Key: 16938853
• MDR Text Key: 315312758
• Report Number: MW5117530
• 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: 05/10/2023

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 Operator: Lay User/Patient
• Device Expiration Date: 08/16/2023
• Device Lot Number: 53K38N5T1
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2023
• Patient Sequence Number: 1