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 12/13/2022

Event Type  malfunction  

Event Description

The customer observed false negative sars-cov-2 igg ii quant results for one patient, who experienced a covid-19 infection.The following data was provided (<50.0 au/ml is negative, >/=50.0 au/ml is positive): sample id (b)(6): initial result was 27.30, repeat was 25.10 au/ml.The sample was repeated, using roche assays, and the results were 12.17 ae/ml and 38.35 coi, which are positive.There was no impact to patient management reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.This report is being filed on an international product, list number 06s60-22 (sars-cov-2 igg ii quant) that has a similar product distributed in the us, list number 06s60-20 (advisedx sars-cov-2 igg ii), eua# (b)(4).

Manufacturer Narrative

Returned patient sample testing was performed on (b)(6) 2023, as part of the complaint investigation, with the following results: architect sars-cov-2 igg ii quant assay lot 46110fn00: 30.9 au/ml (negative).The result obtained in house is comparable to the customer¿s results of 27.30 and 25.10 au/ml.Architect sars-cov-2 igg: 2.50 index (positive).Architect sars-cov-2 igm: 0.02 index (negative).The architect 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, whereas the architect sars-cov-2 igg assay is designed to detect igg antibodies to the nucleocapsid protein of sars-cov-2.In this case, the patient may have a stronger response to the nucleocapsid protein.It is noted that the sars-cov-2 igg ii results although negative are elevated indicating the patient produced an immune response.Based on the investigation, architect sars-cov-2 igg ii quant reagent, lot number 46110fn00, is performing as intended, no systemic issue or deficiency of the reagent was identified.

Manufacturer Narrative

The complaint investigation for false negative architect sars-cov-2 igg ii quant results included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.Sensitivity and specificity testing was done using an in-house retained kit of lot 46110fn00, stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lot is performing acceptably.Device history record review on lot 46110fn00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.The customer obtained negative results for one patient sample when testing was performed with architect sars-cov-2 igg ii quant reagent, lot 46110fn00 in comparison to positive results on roche (nucleocapsid and spike assays).It was reported that the patient experienced covid-19 infection, however symptom onset date or pcr positive date was not provided.In this case, it was reported that the patient experienced covid-19 infection, however symptom onset date or pcr positive date was not provided.No information regarding the patient¿s immunocompromisation status was provided.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.Although negative, the results obtained for the patient sample are elevated indicating the patient produced an immune response.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.The ticket text documents that add scientific affairs provided reference to the publication ¿longitudinal variation in sars-cov-2 antibody levels and emergence of viral variants: implications for the ability of serological assays to predict immunity¿, muecksch f et al med, rxiv preprint doi: https://doi.Org/10.1101/2021.07.02.21259939.This publication 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.Per the clinical performance section of the package insert, assay sensitivity (ppa) at = 15 days post-symptom onset is 99.37% (95 % ci 96.50, 99.97).When immunocompromised specimens were included in the assessment, the observed ppa at = 15 days post-symptom onset was 97.02% (95% ci: 93.22, 98.72).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.Based on the investigation, architect sars-cov-2 igg ii quant reagent, lot number 46110fn00, is performing as intended, no systemic issue or deficiency of the 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: 16134385
• MDR Text Key: 307196949
• Report Number: 3008344661-2023-00014
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2023
• Device Catalogue Number: 06S60-22
• Device Lot Number: 46110FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6).; ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6).; ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6).