MAUDE Adverse Event Report: DIASORIN S.P.A. LIAISON SARS-COV-2 S1/S2 IGG; QUALITATIVE DETECTION OF IGG ANTIBODIES TO SARS-COV-2

Catalog Number 311460

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Diasorin (b)(4) received a complaint from a customer stating that device's suspected false positive reactivity was detected as part of a scientific study.Single mdr related to each involved batch is submitted: lot 258005 mdr code 9610240-2021-00022; lot 258007; lot 258008 mdr code 9610240-2021-00024; diasorin (b)(4) received a complaint from a customer stating that discrepancies were detected comparing diasorin liaison sars-cov-2 s1/s2 igg results with abbott architect results.Based on data analysis, positive and negative controls were found only twice out of the manufacturer's ranges.Customer repeated testing of discordant samples and all index values were lower.Four of the samples, initially resulted positive, resulted as negative upon re-testing.Variation may be generally expected when a test is detecting antibodies, since different antibodies families are present depending on the patient and can be detected in different ways by different antigens and/or methods.In addition, differences between methods might be observed because of different kind of solid phase, different antigen preparation and concentration origins.Complaint was classified as not confirmable.As reported on ifu, the liaison sars-cov-2 s1/s2 igg assay and its clinical performance were based on clinical sensitivity defined by pcr positive; no comparison studies with other serological tests are available.Differences with competitor tests may be expected and cannot be related to product deficiencies.

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 (b)(4) received a complaint from a customer stating that discrepancies were detected comparing diasorin liaison sars-cov-2 s1/s2 igg results with abbott architect results.

• Brand Name: LIAISON SARS-COV-2 S1/S2 IGG
• Type of Device: QUALITATIVE DETECTION OF IGG ANTIBODIES TO SARS-COV-2
• Manufacturer (Section D): DIASORIN S.P.A.; via crescentino snc; saluggia, vercelli 13040 ; IT 13040
• Manufacturer (Section G): DIASORIN S.P.A.; via crescentino snc; saluggia, vercelli 13040 ; IT 13040
• Manufacturer Contact: barbara belluati ; via crescentino snc; saluggia, vercelli 13040 ; IT 13040
• MDR Report Key: 11988954
• MDR Text Key: 259192156
• Report Number: 9610240-2021-00023
• 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: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2020
• Device Catalogue Number: 311460
• Device Lot Number: 358007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1