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 04/07/2022

Event Type  malfunction  

Manufacturer Narrative

The customer stated that the patient sample had been discarded.Internal testing was conducted on 21apr2022 using liaison sars-cov-2 trimerics igg (p/n 311510d) lot 135971, on two xl instruments (sn (b)(4) and s/n (b)(4)).Liaison sars-cov-2 trimerics igg control set (p/n311511d) lot 135973 and 6 internal qc samples were run.The two samples (qc018 and qc012) with ranges around the assay cutoff (>/=13.0 au/ml) were run in replicates of 5, all other samples were run in duplicate.The kit controls and internal qc samples resulted within established ranges on both xl instruments.No product problem has been identified as the testing shows the liaison sars-cov-2 trimerics igg is performing as expected.The customer patient sample results, 11.4 au/ml and 14.3 au/ml, were very close to the assay cut-off of 13.0 au/ml.As the patient sample is no longer available for further analysis no additional investigation is possible.

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 a patient sample, cov2tg sample id 09581001780z, did not repeat when run on liaison®sars-cov-2 trimerics igg.The patient sample was run on 2 different liaison® xl analyzers in the customers laboratory on the same day and was negative (11.4au/ml) initially and positive (14.3 au/ml) upon repeat testing on a different liaison® xl analyzer.The customer reported the negative patient test result to the clinician and then did a corrected report to the clinician and reported the positive result.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: 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: 14310288
• MDR Text Key: 299713752
• Report Number: 2182595-2022-00003
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EUA 202996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• 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: 135971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• 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