MAUDE Adverse Event Report: DIASORIN INC LIAISON SARS-COV-2 TRIMERICS IGG; QUALTATIVE 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 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the performance of liaison sars-cov-2 trimerics igg kit, lot number 135907 was performed and no product problem was identified.Diasorin performed testing on retain material of lot number 135907 and a valid calibration was obtained and all internal qc samples resulted within range.The alleged false negative results were isolated to a particular liaison sars-cov-2 trimerics igg kit integral, serial number ((b)(4).Integral serial number (b)(4) was not available for evaluation because the customer disposed of it.This report is being filed on an international product, part number 311510, lot number 135907 that has a similar product distributed in the us under eua, part number 311510d.

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 too recur there is a non-remote potential for a patient to incur a serious injury/death.Diasorin inc.Received a customer complaint alleging false negative liaison sars-cov-2 trimerics igg results for vaccinated patients.The customers also obtained sporadic failing calibrations and positive controls failing low out of the established range.None of the alleged false negative patient results were reported out side of the laboratory.The customer did not provide any patient information.No impact to patient management was reported.

• Brand Name: LIAISON SARS-COV-2 TRIMERICS IGG
• Type of Device: QUALTATIVE 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: 13890710
• MDR Text Key: 297741142
• Report Number: 2182595-2022-00002
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2022
• Device Catalogue Number: 311510
• Device Lot Number: 135907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• 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