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 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Diasorin (b)(4) received a complaint from a customer stating that two patient samples, initially graded as positive, resulted as negative when re-tested (lot number 358007, system 2210002411).These patient samples were then run on another analyzer and resulted negative again.It was suggested to check all pre-analytical steps and to strictly follow the procedures reported in ifu.No further issues or reproducibility problems were detected by customer: the event was considered isolated to specific samples and was resolved after customer re-spun (centrifuged) the samples.No product problem was identified.Complaint was confirmed due to the occurrence of the event.No clear root cause could be identified and probable causes could be handling-related.The performances of the liaison sars-cov-2 s1/s2 igg assay was verified and confirmed to be coherent with the claimed one.

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 two patient samples, initially graded as positive, resulted as negative when re-tested.

• 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: 12013591
• MDR Text Key: 259721971
• Report Number: 9610240-2021-00015
• 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: 06/16/2021
• 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