MAUDE Adverse Event Report: LUSYS LABORATORIES, INC. COVID19 TEST; REAGENT, CORONAVIRUS SEROLOGICAL

Device Problem False Negative Result (1225)

Patient Problem Virus (2136)

Event Date 07/01/2020

Event Type  malfunction  

Event Description

Lusys laboratories, located in (b)(4) , the company is selling test that gives false negative, i had 4 patients all pcr positive, when we apply lusys lab test the result were negative after 2 weeks after positive result with pcr.Lusys laboratories represents a danger to our society.Fda safety report id# (b)(4).

• Brand Name: COVID19 TEST
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): LUSYS LABORATORIES, INC.
• MDR Report Key: 10436135
• MDR Text Key: 204003665
• Report Number: MW5096160
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 55