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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Diasorin (b)(4) received a complaint from a customer requesting what may cause strong false positive reactions (~300-400 au) consistently, other than cross-reactivity from pre-existing antibodies.Customer stated that a tested patient resulted consistently strong positive for few months.This patient was a hypertension pre-kidney transplant patient that has been tested regularly for 4-5 months and was consistently resulting at values of >400au.The customer assessed the patient by an autoimmune panel and no anomalies were highlighted.The patient was part of a history and population study and a 2-year old sample resulted at > 400au on diasorin assay.Data obtained by the customer showed that sample was graded negative with both abbott and euroimmun assays and that low doses were received from testing.The sample was tested on liaison xl s/n 2210003174 on 28th september 2020 and resulted high positive with the liaison sars-cov-2 s1/s2 igg assay.Diasorin controls were tested and fell within coa ranges.Performance looked adequate on controls based on the data provided.The customer used the liaison sars-cov-2 s1/s2 igg lot 358010.Based on data obtained in-house at batch release, 500 blood donor samples were tested and the following results were obtained for kit lot 358010: 99.8%.Therefore, the internal testing demonstrated that kit lot 358010 met specifications (ifu claim for negative percent agreement: 99.3% with a 95% ci of 98.6-99.6%).Based on the information provided, the complaint was classified as confirmed due to the occurrence of the event.The investigation conclusion reported that no clear root cause could be identified: probable causes are most likely to be instrument- or handling-related.Performances of liaison® sars-cov-2 s1/s2 igg kit (ref 311460) was verified and confirmed to be coherent with the claimed one.Based on the available information, the issue experienced by the customer could be sample-related.No further information are available in addition to the one reported in the ifus (chapter 14) about possible interfering substances and/or aspects which may lead to inaccurate results.Release batch sheet and nc data base were reviewed without highlighting anomalies.

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 a tested patient resulted consistently strong positive for few months.

• 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: 11997291
• MDR Text Key: 259384245
• Report Number: 9610240-2021-00009
• 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: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2020
• Device Catalogue Number: 311460
• Device Lot Number: 358010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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