MAUDE Adverse Event Report: DIASORIN ITALIA S.P.A. LIAISON SARS-COV-2 AG; SARS-COV-2 ANTIGEN DETECTION TEST SYSTEM

Catalog Number 311500

Device Problem False Negative Result (1225)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

In light of the covid-19 pandemic and the subsequent authorizations (euas) for sars-cov-2 diagnostics tests and per the conditions of the emergency use authorization, suspected false negatives, false positives and significant changes in expected performance characteristics will be reported under 21 cfr 803.The alleged false test results in this event have not caused patient injury or death; however, this event is being reported conservatively because if the alleged malfunction were to recur there is a non-remote potential for serious injury or death.Diasorin italia s.P.A.Received a complaint about potential false negative result of cov-2 antigen (ref: 311500 lot 373030).

• Brand Name: LIAISON SARS-COV-2 AG
• Type of Device: SARS-COV-2 ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): DIASORIN ITALIA S.P.A.; via crescentino snc; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 18934258
• MDR Text Key: 338455470
• Report Number: 9610240-2024-00001
• 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: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 311500
• Device Lot Number: 373030
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Patient Sequence Number: 1