MAUDE Adverse Event Report: ABBOTT IRELAND SARS-COV-2 IGG II QUANT REAGENT KIT; REAGENT, CORONAVIRUS SEROLOGICAL

Catalog Number 06S61-22

Device Problem False Positive Result (1227)

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

Event Date 12/16/2021

Event Type  malfunction  

Event Description

The customer suspects false positive alinity i sars-cov-2 igg ii quant.Results possibly due to the patient being treated with sotrovimab (monoclonal antibody) causing cross reactivity to be shown when using the sars-cov-2 igg ii assay.The following data was provided: before administering sotrovimab: on (b)(6) 2021: sars-cov-2 igg ii: 38 au/ml; on (b)(6) 2021: sotrovimab was administered, and the result was 17547 au/ml.Before administering of sotrovimab: on (b)(6) 2022: sars-cov-2 igg ii: 4 au/ml; on (b)(6) 2022: sotrovimab was administered, and the result was 26366 au/ml.Before administering of sotrovimab: on (b)(6) 2022: sars-cov-2 igg ii: 0 au/ml; on (b)(6) 2022: sotrovimab was administered, and the result was 8081 au/ml.Before administering of sotrovimab: on (b)(6)2022: sars-cov-2 igg ii: 523 au/ml; on (b)(6) 2022: sotrovimab was administered, and the result was 13930 au/ml.Before the administration of sotrovimab: on (b)(6) 2022: sars-cov-2 igg ii: 1613 au/ml; on (b)(6) 2022: sotrovimab was administered, and the result was 17610 au/ml.Before administering of sotrovimab: on (b)(6) 2022: sars-cov-2 igg ii: 212 au/ml; on (b)(6) 2022: sotrovimab was administered, and the result was 13007 au/ml.There was no impact to patient management reported.

Manufacturer Narrative

All available patient information is included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 06s61-22 (sars-cov-2 igg ii quant) that has a similar product distributed in the us, list number 06s61-20/-30 (advisedx sars-cov-2 igg ii), eua(b)(4).

Manufacturer Narrative

The complaint investigation for false positive alinity i sars-cov-2 igg ii quant.Results included a search for similar complaints, and the review of complaint text, trending data, labeling, in-house testing, and device history records.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending did not identify any related trends for the product for the issue.A review of the device history record did not identify any non-conformances, potential non-conformances or deviations associated with the lot number and complaint issue.The reagent lot 36068fn00 has expired, however historical specificity testing was performed using an in-house retained kit of the complaint lot 36068fn00.All specifications were met indicating the lot performed acceptably.Labeling was reviewed and adequately addresses the issue under review.In this case, per product labeling, results should be used in conjunction with other data; e.G., symptoms, results of other tests, and clinical impressions.Results from antibody testing should not be used as the sole basis to diagnose or exclude sars-cov-2 infection or to inform infection status.Per the intended use section of the package insert, the sars-cov-2 igg ii quant assay is designed to detect immunoglobulin class g (igg) antibodies, including neutralizing antibodies, to the receptor binding domain (rbd) of the s1 subunit of the spike protein of sars-cov-2 in serum and plasma from individuals who are suspected to have had coronavirus disease (covid-19) or in serum and plasma of individuals that may have been infected by sars-cov-2.Infection is mediated by interaction of the sars-cov-2 rbd with the ace2 viral receptor on host cells.Antibodies to spike rbd can inhibit binding to the ace2 receptor, generating a strong viral neutralizing response.Abbott product labeling does not contain information in relation to sotrovimab.The sotrovimab fact sheet documents that sotrovimab is a human immunoglobulin g-1 (igg1-kappa) monoclonal antibody authorized for use for the treatment of mild-to-moderate coronavirus disease 2019 (covid-19).It binds to a conserved epitope on the spike protein receptor binding domain of sars-cov-2 and inhibits an undefined step that occurs after virus attachment and prior to fusion of the viral and cell membranes and therefore acts to neutralize sars-cov-2.As it is a neutralizing igg antibody that binds to the rbd, it mimics the neutralizing antibodies produced by the body in response to infection or vaccination and therefore it is likely that it would be measured by the assay.Based on the investigation, alinity i sars-cov-2 igg ii quant.Reagent lot 36068fn00 is performing as intended, no systemic issue or product deficiency of the alinity i sars-cov-2 igg ii quant.Reagent was identified.

• Brand Name: SARS-COV-2 IGG II QUANT REAGENT KIT
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15779590
• MDR Text Key: 304973405
• Report Number: 3008344661-2022-00155
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2022
• Device Catalogue Number: 06S61-22
• Device Lot Number: 36068FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODULE, 03R65-01, (B)(6); ALNTY I PROCESSING MODULE, 03R65-01, (B)(6)