MAUDE Adverse Event Report: ORASURE TECHNOLOGIES, INC. INTELISWAB COVID-19 RAPID TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Patient Problem Viral Infection (2248)

Event Date 10/26/2023

Event Type  Injury  

Event Description

Reporter calling, stating the inteliswab covid tests being given out at the "public library in (b)(6)" are faulty.Reporter states she obtained four boxes of inteliswab covid tests from her local library, and each box contains two covid tests.Reporter states she has had eight negative results using the inteliswab covid-19 rapid test, but that she actually has covid-19.Reporter states she must regularly covid test for her job, and she has tested positive for covid with binaxnow, ihealth, and flowflex, however she continues to test negative using inteliswab, and states these negative results are incorrect.Reporter states she has concerns that faulty covid tests are available at her local library for distribution to the public."1001-0622, (b)(6), 608337001624".Reference reports: mw5147412, mw5147413, mw5147414.

• Brand Name: INTELISWAB COVID-19 RAPID TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ORASURE TECHNOLOGIES, INC.
• MDR Report Key: 18031051
• MDR Text Key: 326906510
• Report Number: MW5147415
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Treatment: BINAXNOW COVID TEST; FLOWFLEX COVID TEST; IHEALTH COVID TEST
• Patient Sex: Female