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

Lot Number COV1120165

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 04/27/2022

Event Type  malfunction  

Event Description

Unable to use antigen home / test; i caught covid (b)(6) 2022.Sick with "4 degree" temp on (b)(6) 2022.By (b)(6) 2022 went to (b)(6) to get acon flowflex covid antigen home test.Went home.Tried to use test.Step 8 not possible, "dropper cap" too big to fit in vial.Major manufacturing flaw.No test done.Called the help line to report it.They did not believe me.This product should be recalled.Lot: cov1120165 asap.Please confirm and let me know.Fda safety report id# (b)(4).

• Brand Name: FLOWFLEX
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 14336822
• MDR Text Key: 291324769
• Report Number: MW5109583
• 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: 05/04/2022

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 Lot Number: COV1120165
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White