MAUDE Adverse Event Report: ACON LABORATORIES, INC. COVID-19 ANTIGEN HOME TEST; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Catalog Number L031-118B5

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Malaise (2359); Cough (4457)

Event Date 11/15/2022

Event Type  Injury  

Event Description

Rebound covid-19 test after anti-viral, molnupiravir.Regular course of tx, 2 negative tests.Next day tested positive again.Only symptoms productive cough and mild malaise.Fda safety report id# (b)(4).

• Brand Name: COVID-19 ANTIGEN HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 15825564
• MDR Text Key: 304001479
• Report Number: MW5113344
• Device Sequence Number: 2
• Product Code: QKP
• Combination Product (y/n): Y
• 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: 11/15/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/10/2023
• Device Catalogue Number: L031-118B5
• Device Lot Number: COV2010023
• Patient Sequence Number: 1
• Treatment: AMLODIPINE; AORTIC HEART VALVE ; LOSARTIN/HCTZ; METOPROLOL; PACEMAKER; VITAMIN D; WARFARIN
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White