MAUDE Adverse Event Report: DIASORIN INC. DIASORIN LIAISON MDX COVID-19 DIAGNOSTIC INSTRUMENT; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Model Number 1D0076

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

(b)(6) hospital uses one cepheid and 3 diasorin liaison mdx covid-19 testing instruments in our laboratory.A trend was noted over the weekend where we had an abnormally high number of covid-19 positive tests.We initiated a root cause analysis of the situation and it revealed the following.All three diasorin instruments were contaminated with covid-19 following manufacturer cleaning guidelines.We contacted the manufacturer and deep cleaned all three instruments at least a dozen times and the machines continued to remain contaminated with covid-19.The company is sending a field scientist to inspect, decontaminate and re-certify individual instruments on (b)(6) 2021.Manufacturer aware, hospital working to mitigate situation.Currently not using any of the contaminated machines.Fda safety report ids # (b)(4).

• Brand Name: DIASORIN LIAISON MDX COVID-19 DIAGNOSTIC INSTRUMENT
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): DIASORIN INC.
• MDR Report Key: 12331442
• MDR Text Key: 267049513
• Report Number: MW5103271
• Device Sequence Number: 1
• Product Code: QKP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/12/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1D0076
• Device Lot Number: US12573
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other