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 10/17/2022

Event Type  malfunction  

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 ran four instand survey samples which resulted as follows, (b)(6) (instand 416067) 169 bau/ml, (b)(6) (instand 416068) >2080 bau/ml, (b)(6) (instand 416069) 1500 bau/ml and (b)(6) (instand 416070) 33.7 bau/ml.Sample (b)(6) (instand 416070) was low out of the acceptable instand survey range.Sample (b)(6) (instand 416070) was repeated by the customer in two replicates on (b)(6) 2022 and resulted at 42.1 and 41.8 bau/ml which falls within the acceptable instand survey range.Internal testing performed by diasorin inc.On (b)(6) 2022 with liaison sars-cov-2 trimerics igg (p/n: 311510 lot: 136290), liaison sars-cov-2 trimerics igg control set (p/n: 311511 lot: 136116) and five internal quality control samples was evaluated and no product problem was identified.Liaison sars-cov-2 trimerics igg control 1 range is n.A.To 15.6 bau/ml, control 2 range is 66.5 to 123 bau/ml.Control 1 resulted at <4.81 bau/ml and control 2 resulted at 94.5 bau/ml.Both liaison sars-cov-2 trimerics igg controls and all internal qc samples resulted within the established ranges, including those near the assay cutoff of 33.8 bau/ml.The assay met all specifications and performed as intended.

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 they failed an external survey, instand sars-cov-2 ak-rv because the fourth sample of the survey, id number (b)(6), was reported as 33.7 bau/ml = neg.The expected result was equivocal or positive.The customer did not provide any patient information and no impact to patient management was reported.

• 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: 16381984
• MDR Text Key: 309611962
• Report Number: 2182595-2022-00005
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2022
• Device Catalogue Number: 311510
• Device Lot Number: 136290
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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