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

Model Number FLOWFLEX

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Contamination of Device Ingredient or Reagent (2901)

Patient Problem Viral Infection (2248)

Event Date 04/06/2023

Event Type  malfunction  

Event Description

I was trying to use a covid test and when i opened the buffer vial there was a worm in it.An actual worm.Test is positive/negative.

• Brand Name: FLOWFLEX COVID-19 ANTIGEN HOME TEST
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 16726485
• MDR Text Key: 313207553
• Report Number: MW5116548
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/23/2023
• Device Model Number: FLOWFLEX
• Device Catalogue Number: L-031-118B5
• Device Lot Number: COV2020172
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: CALCIUM ; ESTROGEN REPLACEMENT; LEVOTHYROXIN; MAGNESIUM SUPPLEMENTS; VITAMIN D
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White