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 stating that the liaison sars-cov-2 s1/s2 igg assay did not pass their specificity study.The customer stated they had 100 pre-covid samples, collected from september to october 2019, and six of them resulted positive with diasorin assay (94% specificity), whereas they were negative with three other platforms (abbott, roche and beckman).Positive and negative results were based on comparison to another method.Diasorin assay and clinical performance were based on clinical sensitivity defined by pcr positive and analyzed depending on the days from diagnosis.Moreover, according to literature there is not a consensus on when the pandemic began, therefore without a pcr result these patients cannot be confirmed as negative at that time.Data were analysed and the complained samples were identified.All samples were retested obtaining repeatedly positive results.Diasorin controls were tested on the relevant routine days and fell within manufacturer's ranges.Maintenance was performed according to recommendations.It was suggested to pay attention to pre-analytical steps, centrifugation setting and sample appearance.The complaint was classified as confirmed.No clear root cause could be identified and probable causes could be instrument- or handling-related.The performances of the liaison sars-cov-2 s1/s2 igg assay were 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 the liaison sars-cov-2 s1/s2 igg assay did not pass their specificity study.

• 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: 11989080
• MDR Text Key: 259104376
• Report Number: 9610240-2021-00035
• 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: 10/06/2021

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: 10/11/2020
• Device Catalogue Number: 311460
• Device Lot Number: 358005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• 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