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

Catalog Number 06R86-22

Device Problem False Negative Result (1225)

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

Event Date 02/09/2022

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 6r86-22 (sars-cov-2 igg) and has a similar product distributed in the us, list number 6r86-20/-30 (sars-cov-2 igg: eua # (b)(4).

Event Description

The customer observed a false negative sars-cov-2 igg result generated on the architect i2000sr processing module for two patients that had a past exposure to covid 19.The following data was provided: patient 1: (b)(6) 2022 sid (b)(6) initial result = 0.27 index (negative), (b)(6) 2021 roche sars-cov-2 s protein ab = 249.00 u/ml (positive, anti-s cutoff <0.80), (b)(6) 2021 hologic aptima sars-cov-2 rna = not detected.Patient 2: sid: (b)(6) 2022 (b)(6) se initial result = 0.89 index (negative), (b)(6) 2022 roche sars-cov-2 s protein ab was >5000.00 u/ml (positive, anti-s cutoff <0.80), roche sars-cov-2 n protein ab = 3.150 (positive, anti-n cutoff <1.0), no sars-cov-2 rna performed.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false negative sars-cov-2 igg results included a search for similar complaints, and the review of complaint text, trending data, labeling, scientific literature and device history records.Return testing was not completed as returns were not available.In-house sensitivity and specificity testing for reagent lot 33209fn00 was completed using a retained sample of the complaint lot.All specifications were met indicating the lot is performing acceptably.Device history record review on lot 33209fn00 did not show any nonconformances, potential nonconformances, or deviations associated with the complaint issue.Labeling was reviewed which adequately address the issue under review.A direct comparison should not be made between the sars-cov-2 igg assay and the roche assays.The roche assays are total antibody assays.The sars-cov-2 igg is designed to detect immunoglobulin class g (igg) antibodies to the nucleocapsid protein of sars-cov-2 whereas the roche total ab n assay is designed to detect antibodies (including igg) the nucleocapsid protein of sars-cov-2 and the roche total ab s is an immunoassay for the in vitro quantitative determination of antibodies (including igg) to the sars-cov-2 spike (s) protein receptor binding domain (rbd) in human serum and plasma.As part of evaluating the consistency of sars-cov-2 igg lots, abbott has conducted comparison studies using a third party manufactured sample set (seracare sars-cov-2 performance panel).This provided a basis for comparison with the roche cobas anti-sars-cov-2 assay, another nucleocapsid based test capable of detecting igg (as well as potentially igm and iga).Testing was performed using five different abbott lots with comparative results showing good lot-to-lot consistency, with the abbott igg assay correctly identifying 10 of 10 positive panel members.The negative panel member tested as negative on all abbott lots.In comparison, the roche assay detected 9 of 10 positive panel members (roche testing performed by seracare).Based on current literature, long, q-x et al, ¿https://www.Nature.Com/articles/s41591-020-0897-1¿, igg levels may not appear until 7 to 10 days after infection.In addition, emerging literature on sars cov-2 serology indicates that antibody responses to the virus decline over time.In some cases, this transient response results in the decline of both igg and neutralizing antibody titers.It remains unknown for how long antibodies persist following infection and if the presence of antibodies is indicative of protective immunity, seow et al, ¿https://doi.Org/10.1101/2020.07.09.20148429¿, and ou et al, ¿https://doi.Org/10.1101/2020.05.22.20102525¿.The study, quan-xin long et al, ¿clinical and immunological assessment of asymptomatic sars-cov-2 infections¿, nature medicine, observed that igg levels and neutralizing antibodies in a high proportion of individuals who recovered from sars-cov-2 infection start to decrease within 2¿3 months after infection.To assess the clinical performance of the assay, a study was performed using 122 serum and plasma specimens collected at different times from 31 subjects who tested positive for sars-cov-2 by a polymerase chain reaction (pcr) method and who also presented with covid-19 symptoms.The positive percent agreement (ppa) at >/=14 days post-symptom onset is 100.00% (95% ci: 95.89, 100.00).Five specimens from 1 immunocompromised patient were excluded from the study.When the results from these specimens were included, the ppa at >/=14 days post-symptom onset was 96.77% (95% ci: 90.86, 99.33).This study was based on a hospitalized/symptomatic population.Differences in antibody responses between populations, based on more severe versus less severe illness, are consistent with published reports, zhao j et al.2020.Additionally, review of the manuscript ¿performance characteristics of the abbott architect sars-cov-2 igg assay and seroprevalence in boise, idaho¿, bryan et al.2020, showed sensitivity data consistent with product labeling.125 patients who tested rt-pcr positive for sars cov-2 for which 689 excess serum specimens were available was tested and it was found that sensitivity reached 100% at day 17 after symptom onset and day 13 after pcr positivity.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 sars-cov-2 igg reagent lot 33209fn00 is performing as intended, no systemic issue or deficiency of the sars-cov-2 igg reagent was identified.

Event Description

The customer observed a false negative sars-cov-2 igg result generated on the architect i2000sr processing module for two patients that had past exposure to covid 19.The following data was provided: patient 1: (b)(6) 2022 sid (b)(6) initial result = 0.27 index (negative), (b)(6) 2021 roche sars-cov-2 s protein ab = 249.00 u/ml (positive, anti-s cutoff <0.80), (b)(6) 2021 hologic aptima sars-cov-2 rna = not detected patient 2: (b)(6) 2022 sid: (b)(6) initial result = 0.89 index (negative), (b)(6) 2022 roche sars-cov-2 s protein ab was >5000.00 u/ml (positive, anti-s cutoff <0.80), roche sars-cov-2 n protein ab = 3.150 (positive, anti-n cutoff <1.0), no sars-cov-2 rna performed no impact to patient management was reported.

• Brand Name: SARS-COV-2-IGG 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: 13636793
• MDR Text Key: 286585403
• Report Number: 3008344661-2022-00016
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2022
• Device Catalogue Number: 06R86-22
• Device Lot Number: 33209FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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, ISR62089.; ARC I2000SR INST, 03M74-02, ISR62089.