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 09/06/2021

Event Type  malfunction  

Event Description

The customer observed false negative sars-cov-2 igg results for several patients on an architect i1000sr analyzer when compared to another method.The following discrepant data was provided (<1.4 index (s/c) is negative; reference range of the diagreat igg assay is >1.00 u/l is positive): sample id (b)(6) initial result was 0.28 index (s/c); when repeated with the diagreat assay result was 80.97 u/l.Sample id (b)(6) initial result was 0.99, repeat was 0.95 index (s/c); when repeated with the diagreat assay result was 341.39 u/l; when tested with biosensor the result was positive.Sample id (b)(6) initial result was 0.33, repeats were 0.31 index (s/c); when repeated with the diagreat assay result was 311.44 u/l; when tested with biosensor the result was positive.Sample id (b)(6) initial result was 0.20, repeat was 0.21 index (s/c); when repeated with the diagreat assay result was 263.21 u/l; when tested with biosensor the result was positive.Sample id (b)(6) initial result was 0.97 index (s/c); when repeated with the diagreat assay result was 290.22 u/l.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.Patient identifier complete entry = sample id (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 06r86-22 (sars-cov-2 igg), that has a similar product distributed in the us, list number 06r86-20 (sars-cov-2 igg assay), eua (b)(4).

Manufacturer Narrative

The complaint investigation for false negative architect sars-cov-2 igg results included a search for similar complaints, the review of complaint text, trending data, labeling, scientific literature, and device history records.Return testing was not complete as patient samples were not available.Sensitivity and specificity testing were done using an in-house retained kit of lot 30393fn00, 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 30393fn00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.The customer observed false negative results for several patients when using architect sars-cov-2 igg, lot number 30393fn00, when compared to diagreat assay.In this case, no specific patient clinical data was provided.A direct comparison should not be made between the architect sars-cov-2 igg assay and the diagreat assay as they use different test methodologies.The diagreat assay uses fluorescence immunochromatography methodology in a rapid test format.Per product labeling for the diagreat ncov igg assay positive results may be due to past or present infection with non-sars-cov-2 coronavirus strains such as coronavirus hku1, nl63, oc43 or 229e.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.Negative results do not rule out sars-cov-2 infection, particularly in those who have been in contact with the virus.Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.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.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.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.Based on the investigation architect sars-cov-2 igg reagent lot 30393fn00 is performing as intended, no systemic issue or deficiency was identified.

• 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, IL N39 E-932 ; 2246682940
• MDR Report Key: 12668290
• MDR Text Key: 284694675
• Report Number: 3008344661-2021-00188
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/26/2021
• Device Catalogue Number: 06R86-22
• Device Lot Number: 30393FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1SR REFURB-MEXICO, 01L86-84, I1SR54712; ARC I1SR REFURB-MEXICO, 01L86-84, I1SR54712