MAUDE Adverse Event Report: DIASORIN INC LIAISON SARS-COV-2 TRIMERICS IGG; QUALITATIVE IVD TEST KIT FOR THE DETECTION OF ANTIBODIES TO SARS-COV-2

Catalog Number 311510

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2022

Event Type  malfunction  

Event Description

In light of the covid-19 pandemic and the subsequent emergency use authorizations (euas) for sars-cov-2 diagnostic tests, per the conditions of authorization for this product, suspect false negatives and false positives will be reported under 21cfr 803, as well as significant changes in expected performance characteristics.There has been no report of patient injury/death due to contribution of alleged false testing results in this event or others with this ivd; however, this is being reported conservatively in the case that if this alleged malfunction were to recur there is a non-remote potential for a patient to incur a serious injury/death.Diasorin inc.Received a customer complaint alleging that several cases of non-vaccinated, pcr-confirmed sars cov2 patients, several months after the onset of infection, results as 0 bau/ml in the liaison sars-cov-2 trimerics igg assay with simultaneously strongly positive nucleocapsid values.The customer did not feel this was plausible.The customer did not provide any patient information and no impact to patient management was reported.

Manufacturer Narrative

This report is being filed on an international product, part number 311510 that has a similar product distributed in the us under eua, part number 311510d.The customer did not provide product lot information but a review of their purchase orders determined that they were most likely using liaison sars-cov-2 trimerics igg lot no.135970.Internal testing of lot 135970 was performed on april 5, 2022 and all quality control samples and kit controls were within range and near the mean indicating that the product is performing as intended.The discrepancy in patient test results is likely due to the fact that the liaison sars-cov-2 trimerics igg assay uses the full length spike protein as the detection antigen and may not directly compare to results from an assay that uses a different antigen such as the nucleocapsid protein.Individual subjects produce variable antibody responses to different antigens of sars-cov-2 and may not generate comparable results when evaluated in assays utilizing different detection antigens.

• Brand Name: LIAISON SARS-COV-2 TRIMERICS IGG
• Type of Device: QUALITATIVE IVD TEST KIT FOR THE DETECTION OF ANTIBODIES TO SARS-COV-2
• Manufacturer (Section D): DIASORIN INC; 1951 northwestern ave.; stillwater MN 55082 0285
• Manufacturer (Section G): DIASORIN INC; 1951 northwestern ave.; stillwater MN 55082 0285
• Manufacturer Contact: kym pieper ; 1951 northwestern ave.; stillwater, MN 55082 ; 6514399710
• MDR Report Key: 14940069
• MDR Text Key: 303735381
• Report Number: 2182595-2022-00004
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EUA 202996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2022
• Device Catalogue Number: 311510
• Device Lot Number: 135970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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