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

Catalog Number 06S60-22

Device Problem False Negative Result (1225)

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

Event Date 10/01/2022

Event Type  malfunction  

Manufacturer Narrative

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 6s60-22 that has a similar product distributed in the us, list number 6s60-20.

Event Description

A journal article by lars müller, judith kannenberg, ronald biemann, mario honemann, grit ackermann, christian jassoy, ¿comparison of the measured values of quantitative sars-cov-2 spike antibody assays¿, journal of clinical virology (155 2022).Documented false negative architect sars-cov-2 igg ii quant results on four patients when compared to the roche platform.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false negative sars-cov-2 igg ii quant results included a search for similar complaints, and the review of the complaint text, literature article, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review on list number 06s60 did not show any potential non-conformances, or deviations associated with the customer¿s observation.Labeling was reviewed and found to adequately address the issue under review.This study looked at performance of different sars-cov-2 spike antibody detecting assays including the abbott architect quantitative igg ii (spike) assay, including comparison of measured values across assays.The study used 110 samples from 55 adults collected 6-7 months and 9 months post infection with sar-cov-2 as diagnosed through rt-pcr.The participants were asymptomatic or had mild/moderate symptoms with none being hospitalized or vaccinated prior to blood draws.There is no indication that the abbott architect quantitative igg ii (spike) assay is not performing as intended.Positivity using the abbott assay was 96.4%, which was higher than that of siemens (69.1%) and eurioimmun (57.3%) and slightly lower than the roche assay (100%).However, the publication points to the fact that assays can differ regarding the target antigen, the immunoglobulin classes that are being measured, and the technical principle.The abbott, siemens and euroimmun tests measure igg antibodies while the roche test measures total antibodies, therefore differences across assays may be expected.The serological response to covid-19 is still an area for further research with variable results being observed across different studies regarding the strength and duration of seropositivity (in this study samples were collected 6-7 months and 9 months post infection).The sars-cov-2 igg ii quant assay is to be used as an aid in the diagnosis of sars-cov-2 infection in conjunction with clinical presentation and other laboratory tests.The assay is also to be used as an aid in evaluating immune status of infected individuals and to monitor antibody response in individuals that have received the covid-19 vaccine, by quantitatively measuring igg antibodies against the spike receptor-binding domain (rbd) of sars-cov-2.In this case, a direct comparison cannot be made as the abbott assay measures igg antibodies while the roche test measures total antibodies.Based on the investigation, no systemic issue or deficiency of the sars-cov-2 igg ii quant reagent lot unknown 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: 15672131
• MDR Text Key: 307110794
• Report Number: 3008344661-2022-00146
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06S60-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, 116UNKNOWN11; ARC I2000SR INST, 03M74-02, 116UNKNOWN11