MAUDE Adverse Event Report: ACON LABORATORIES, INC. FLOWFLEX; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Lot Number COV2020017

Patient Problem Viral Infection (2248)

Event Date 09/21/2023

Event Type  malfunction  

Event Description

This occurred during a clinical study.A covid -19 flowflex antigen test from manufacturer acon provided abnormal results.The affected lot number is cov2020017.A potential study subject had been to a clinic and received a positive covid-19 test using a different manufacturer's antigen test; this was the subject's 1st antigen test.Based on that test result, the subject was referred to the clinical site for screening and enrollment.The clinical study is being conducted using the acon flowflex product.At the clinical site the potential subject was tested with flowflex lot number cov2020017 and tested negative; this was the subject's 2nd antigen test.Due to the contradictory results, the subject was tested a 3rd time at the clinical site with yet a different manufacturer's antigen test and again came back positive.The subject was tested a 4th time with flowflex lot number cov2020017 and came back negative.At this point, the subject had 2 positive tests from 2 different antigen manufacturers and 2 negative tests from the flowflex lot number cov2020017.The clinical site became concerned that there was an issue with flowflex lot number cov2020017.To further investigate, the clinical site then tested the subject a 5th time and used a different flowflex lot number cov2020195 which came back positive.The flowflex lot number cov2020017 provided negative results two times versus three positive results using 3 different manufacturers antigen tests.Each test was a fresh nasal swab.Lateral flow test.Reference report: mw5146641.

• Brand Name: FLOWFLEX
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 17885321
• MDR Text Key: 325371324
• Report Number: MW5146640
• 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: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2024
• Device Lot Number: COV2020017
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1