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 Type  malfunction  

Manufacturer Narrative

Diasorin (b)(4) received a complaint from a customer reporting false positive results obtained with the sars-cov-2 s1/s2 igg assay (lot: 358018).Customer stated the samples were from a diverse population with no previous positive result.The customer did not perform any additional testing for confirmation.The samples were processed fresh or within one day in secondary tubes and were with or without gel.Customer also stated that nothing had changed in their laboratory routine lately.Data has been analysed.Noticed that the diasorin controls were tested during the period analysed and that the diasorin negative control was found in several occasions out of higher coa ranges.Controls were not always retested.Suggested to discuss with the customer about diasorin controls and troubleshooting guidelines as per ifus.Customer started using kit lot 358018 at the beginning of march 2021.Noticed that in general no misclassification was observed on patient specimens upon retest, with the only exception of 6 samples which were excluded from the additional analysis performed (since only two replicates were available pos/neg).The percent of positive samples obtained by week on the three liaison xl analyzers was calculated.Result obtained showed no clear trend in percentage of positive samples.Percentage of positive samples obtained by kit lot was calculated and observed similar percentages.Recommended discussing with the customer maintenance procedure and the importance to perform them in a timely manner in order to guarantee optimal performance of the equipment.It was not possible to retrieve the number of positive samples suspected to be potential false positive from the data received.Further, based on the information received, suspected false positive samples were not retested for confirmation with other methods.Based on the information retrieved and data analysis performed the wo has been classified as not confirmable.No clear root cause could be identified however the issue could be sample-related or related to suboptimal instrument maintenance.Data obtained at batch release on qc panel samples are checked and good consistency was found between kit lots.Review of data obtained at batch release on a population of 500 expected negative samples confirms performance obtained for kit lot 358018 is aligned to ifu claims.

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 reporting false positive results obtained with the sars-cov-2 s1/s2 igg assay.

• 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: 11980219
• MDR Text Key: 258933313
• Report Number: 9610240-2021-00020
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Catalogue Number: 311460
• Device Lot Number: 358018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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