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 reporting false positive results obtained with the sars-cov-2 s1/s2 igg assay (lot: 358008).Customer reported two initial reactive results were obtained.The two discrepant samples belonged to 2 different patients, were refrigerated before the first test and were tested the following day.All the samples were received already spun down and refrigerated.First repeat was run on the original tube and second repeat was aliquoted and spun down.It was reminded to the customer to follow the steps outlined in the ifu for preparation and handling of a sample when repeat testing is necessary.The instrument data showed that the results occurred with the liaison sars-cov-2 s1/s2 igg assay in the period 5 may 2020 - 27 aug 2020.During this timeframe, the customer tested 2509 samples and 139 samples id were retested.4 out of 139 samples id did not match qualitatively in all replicates: - sample id (b)(4), which resulted positive (20.5 au/ml) on august 23, 2020, resulted negative twice (5.19 au/ml and 4.62 au/ml) on august 24, 2020.The testing occurred on kit lot 358008, integral number (b)(4), calibration id (b)(4).- sample id (b)(4), which resulted positive (44.5 au/ml) on august 22, 2020, resulted negative twice (<3.8 au/ml and <3.8 au/ml) on august 24, 2020.The testing occurred on kit lot 358008, integral number (b)(4), calibration id (b)(4).- sample id (b)(4), which resulted positive (19 au/ml) on june 1, 2020, resulted negative (5.69 au/ml) on june 1, 2020.The testing occurred on kit lot 358007, integral number (b)(4), calibration id (b)(4).- sample id (b)(4), which was tested 175 times with several kit lot numbers (358005, 358007 and 358008), resulted always negative except the first time, resulting positive at 26.1 au/ml.Instrument user maintenances were performed according to diasorin's indications.In two cases, a delay was observed for the customer maintenance activities tracked.Based on the analysis performed by diasorin corporate service liaison xl, the involved sample ids were tested for "cov2-g' "in the following dates: · 2020.08.23 and 2020.08.24 (sid (b)(4)) using the "i.Rac" type; · 2020.08.22 and 2020.08.24 (sid (b)(4)) using the "i.Rac" type; · 2020.06.01 ((b)(4)) using the "x.Rac" type; · 2020.05.05, 2020.05.06 and 2020.05.07 ((b)(4)) using the "x.Rac" type.The analysis of the pressure profiles for the jobs related to investigated sids did not highlight any anomaly (both in aspiration or dispensation) that could lead to an unexpected result.A preventative maintenance was managed on 01sep2020.The customer also stated that two further discrepant results were obtained with the sars-cov-2 s1/s2 igg assay.These discrepant results happened on both of their analyzers and seem to be intermittent.The complaint was classified as not confirmable and the root cause could be sample related.Claimed product performances of the involved kit, reported in the instruction for use, are maintained and no trend in performance were observed up to date.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 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: 11981602
• MDR Text Key: 258961500
• Report Number: 9610240-2021-00019
• 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: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 311460
• Device Lot Number: 358008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2020
• 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