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

Model Number	L031118B5
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Had to take unpaid time off; false positive test results.At home test came back positive but pcr test came back negative.Fda safety report id# (b)(4).

• Brand Name: FLOWLEX
• Common Device Name: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): ACON LABORATORIES, INC.
• MDR Report Key: 13358198
• Report Number: MW5106958
• Device Sequence Number: 16707173
• Product Code: QKP
• UDI-Device Identifier: 00682607660261
• UDI-Public: 01006826076602611722121510COV112
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/23/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: L031118B5
• Device Catalogue Number: L031118B5
• Device Lot Number: COV1120161
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Female