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

Catalog Number 06S60-32

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 06s60-32 (sars-cov-2 igg ii quant) that has a similar product distributed in the us, list number 06s60-20/-30 (advisedx sars-cov-2 igg ii), eua (b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported discrepant architect sars-cov-2 igg ii quant.Results for an immunocompromised patient.The following results were: on (b)(6) 2022 sid (b)(6).Architect: 1554 au/ml (i.E.221 bau/ml).Roche (elecsys): 1938 au/ml (i.E.1994.20 bau/ml).The customer stated the patient was tested at the end of november 2021 and generated a sars-cov-2 igg ii quant.Result of 3000 au/ml.The customer¿s decision cutoff is set at 264 bau/ml in order to determine if an immunocompromised patient should receive the 4th dose of vaccine.Given the result of 221 bau/ml from the architect, the patient was given the vaccine, however the roche result of 1994.20 bau/ml, the patient would have not received the vaccine.There was no adverse impact to patient management reported.

Manufacturer Narrative

The complaint investigation for a depressed architect sars cov-2 ii quant.Result included a search for similar complaints, and the review of complaint text, trending data, labeling, 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.The lot search review did not identify an increase in complaint activity for the issue.Review of the tracking and trending for the complaint list number did not identify any related trends regarding commonalities for the lot number and complaint issue.Performance testing was performed using an in-house retain kit of lot 36051fn00.All specifications were met indicating the lot is performing acceptably.A review of the product quality history for the lot number did not identify any issues associated with the customer¿s observation.Labeling was reviewed and adequately addresses the issue under review.In this case, no discrepant results were generated as abbott and roche results were positive.The reason for the decrease in the abbott result is unclear.Per the limitations of the procedure section of the package insert, immunocompromised patients who have covid-19 may have a delayed antibody response and produce levels of antibody which may not be detected as positive by the assay.Per the clinical performance section of the package insert, the assay sensitivity (ppa) at = 15 days post-symptom onset is (b)(4)% ((b)(4) % ci 96.50, 99.97).When immunocompromised specimens were included in the assessment, the observed ppa at = 15 days post-symptom onset was (b)(4)% ((b)(4)% ci: 93.22, 98.72).Regarding the differences in the values between the abbott and roche assays, this could potentially be due to the different assay formats; the abbott assay detects igg whereas the roche assay is a total antibody assay and uses different assay specific scales.Review of the publication by muecksch f et al, ¿longitudinal variation in sars-cov-2 antibody levels and emergence of viral variants: a serological analysis¿ doi: https://doi.Org/10.1016/s2666-5247(22)00090-8, contains performance data for the abbott sars-cov-2 igg ii assay compared to other assays (including roche) for sensitivity over time and correlation to neutralization methods, which shows the good performance of the abbott sars-cov-2 igg ii assay.Per the publication, in addition to indicating whether a serum sample is negative or positive for antibodies against viral antigens, each assay indicates quantitative antibody levels within assay-specific scales.Analysis of antibody levels over time showed assay dependent differences in trajectory that were not dependent on whether nucleocapsid or spike antigens were used.In this study correlation with neutralizing antibody titers was assessed and it was shown that assays measuring spike specific igg antibodies predicted neutralizing antibody titers more accurately than those measuring total antibodies against spike regardless of class or those against the nucleocapsid protein.In addition, declines in antibody levels over time measured with serological assays did not, in some cases, accurately reflect the decrease in neutralization activity.The diasorin assays, abbott iggii, siemens scovg, euroimmun and cpass had the highest correlation with neutralizing antibody titers across all comparisons and changes in quantitative values over time for these assays were most closely correlated with changes in neutralizing antibody levels within individuals.The quantitative results from the aforementioned assays are thus best suited for estimating neutralizing antibody levels at a population level.Muecksch f et al, longitudinal variation in sars-cov-2 antibody levels and emergence of viral variants: a serological analysis.Doi: https://doi.Org/10.1016/s2666-5247(22)00090-8.Results should be used in conjunction with other data; e.G., symptoms, results of other tests, and clinical impressions.Based on the investigation architect sars-cov-2 igg ii quant.Reagent lot 36051fn00 is performing as intended, no systemic issue or deficiency of the architect sars-cov-2 igg ii quant.Reagent was identified.A1 - patient identifier: initial: ni / updated: sid (b)(6) (not enough characters to fit in this field).

• 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: 14280591
• MDR Text Key: 294497419
• Report Number: 3008344661-2022-00041
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• 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: 06S60-32
• Device Lot Number: 36051FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).