MAUDE Adverse Event Report: ABBOTT IRELAND SARS-COV-2 IGM

Catalog Number 06R87-22

Device Problem False Negative Result (1225)

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: sid (b)(6).All available patient information is included.Additional patient details are not available.This report is being filed on an international product, list number 6r87-22 that has a similar product distributed in the us, list number 6r87-20 /-30.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed false negative architect sars-cov-2 igg and architect sars-cov-2 igm results for 2 patients when compared to another method (vector best).The following data was provided: sid (b)(6): sars-cov-2 igm = architect = 12.16 (>/= 1.00 s/c is positive), vector best = 5.2 (cutoff is 1.1); sars-cov-2 igg = architect = 1.02 (< 1.4 s/c is negative), vector best = 5.2 (cut off is 1.1) sid (b)(6): sars-cov-2 igm = architect = 0.47 (< 1.00 s/c is negative), vector best = 1.2 (positive); sars-cov-2 igg = archtiect = 0.43 (negative), vector best = 3.0 (positive) there was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely negative architect sars-cov-2 igg, lot 26754fn00 and architect sars-cov-2 igm, lot 27114fn00 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 possible as returns were not available.In-house testing for reagent lots 26754fn00 and 27114fn00 was completed using a retained sample of the complaint lots stored at the recommended storage condition.All validity and acceptance criteria were met indicating that the lots are performing acceptably.Device history record review on lot 26754fn00 and 27114fn00 did not identify any non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.In this case, specific patient history and the date of the pcr test was not provided for the patient.A direct comparison should not be made between the architect sars-cov-2 igg assay and the vector best sars-cov-2 igg assay.The architect sars-cov-2 igg is designed to detect immunoglobulin class g (igg) antibodies to the nucleocapsid protein of sars-cov-2 whereas the vector best sars-cov-2 igg assay is designed to detect spike antibodies.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.The duration and strength of the igm antibody response continue to be characterized; the kinetics of this response are unknown.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, 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.It remains unknown for how long antibodies persist following infection and if the presence of antibodies is indicative of protective immunity.The study, quan-xin long et al, ¿clinical and immunological assessment of asymptomatic sars-cov-2 infections¿, nature medicine, https://doi.Org/10.1038/s41591-020-0965-6, 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 igg 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.Antibody responses to sars-cov-2 in patients of novel coronavirus disease 2019.Medrxiv.Per the clinical performance section of the igm package insert, a study was performed to estimate the positive percent agreement (ppa), between the sars-cov-2 igm assay and the polymerase chain reaction (pcr) comparator.The specimen cohort assessed in these studies consisted of twenty-eight (28) specimens from 8 immunocompromised patients.When the results from these specimens were excluded from the assessment, the positive percent agreement (ppa) at 15 to 30 days post-symptom onset is 96.67% (95% ci: 90.65, 98.86) and at 15 to 30 days post-positive pcr result is 100.00% (95% ci: 93.47, 100.00).However, when the immunocompromised specimens were included in the assessment, the observed ppa at 15 - 30 days post-symptom onset was 91.26% (95% ci: 84.22, 95.33) and 15 - 30 days post-positive pcr result was 93.94% (95% ci: 85.43, 97.62).It should be noted that the duration of the igm antibody response has not been fully characterized.These study results are representative performance data.Results obtained in individual laboratories may vary.Review of the manuscript, bryan et al.2020, ¿performance characteristics of the abbott architect sars-cov-2 igg assay and seroprevalence in boise, idaho¿, j.Clin.Microbiol, doi: 10.1128/jcm.00941-20, 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.Based on the investigation, architect sars-cov-2 igm, lot 27114fn00 and architect sars-cov-2 igg, lot 26754fn00 are performing as intended, no systemic issue or deficiency of the architect sars-cov-2 igm and architect sars-cov-2 igg reagents were identified.

• Brand Name: SARS-COV-2 IGM
• Type of Device: SARS-COV-2 IGM
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 12269137
• MDR Text Key: 265586917
• Report Number: 3008344661-2021-00153
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2021
• Device Catalogue Number: 06R87-22
• Device Lot Number: 27114FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC COV2 IGG 500T OUS, 06R86-32, 26754FN00; ARC COV2 IGG 500T OUS, 06R86-32, 26754FN00; ARC I2000SR INST, 03M74-02, ISR60788; ARC I2000SR INST, 03M74-02, ISR60788