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

Catalog Number 06S60-22

Device Problem False Negative Result (1225)

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

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: (b)(6).Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed a false negative sars-cov-2 igg ii quant result generated on the architect i1000sr processing module for a patient who received the sinovac vaccination.The following data was provided (reference range: >/= 50 au/ml is positive): sid (b)(6) initial result = 48 au/ml no impact to patient management was reported.

Manufacturer Narrative

This report is being filed on an international product, list number 6s60-22 (sars-cov-2 igg ii quant ) and has a similar product distributed in the us, list number 6s60-20/-30 (advisedx sars-cov-2 igg ii: eua #(b)(4).The complaint investigation for false negative sars-cov-2 igg ii quant 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 specificity and sensitivity testing for reagent lot 28453fn00 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 28453fn00 did not show any potential non-conformances, or deviations associated with the complaint issue.Labeling was reviewed which adequately address the issue under review.Per product labeling, specimens from patients who have received preparations of mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies (hama).Such specimens may show either falsely elevated or depressed values when tested with assay kits such as sars-cov-2 igg ii quant that employ mouse monoclonal antibodies.Rheumatoid factor (rf) in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.In this case no specific patient data 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.Per the clinical performance section of the package insert, the 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.Review of the article, zhiwei wu et al, ¿safety, tolerability, and immunogenicity of an inactivated sars-cov-2 vaccine (coronavac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial", lancet infect dis 2021;21: 803¿12, https://doi.Org/10.1016/s1473-3099(20)30987-7, concluded that coronavac was well tolerated and induced humoral responses in adults aged 60 years and older, which supports the use of this vaccine in an older population.This study is ongoing.The article also documents that studies have shown that individuals aged 60 years or older, and especially those with underlying chronic conditions, have an increased risk of severe illness and death compared with younger people, and that this risk increases with age.The response to vaccines is usually reduced in older adults because of immune senescence, the age-related changes that affect many of the cellular and molecular elements of both the innate and adaptive immune systems.Therefore, testing the effectiveness of covid-19 vaccines in this population is necessary.Per the publication, florian krammer, ¿sars-cov-2 vaccines in development¿, nature, vol 586, 22 october 2020, https://doi.Org/10.1038/s41586-020-2798-3, sinovac reported results from a randomized, double-blind, placebo-controlled phase ii trial (nct04352608) of the inactivated vaccine coronavac.Overall, more than 90% of individuals showed seroconversion.Notably, the authors also stratified the titres by age.It was found that individuals between 18 and 39 years old had notably higher antibody responses than older individuals, suggesting that perhaps higher doses or different adjuvants might be needed for the latter group.The vaccine is currently being evaluated in phase iii clinical trials in adults, including in older adults (nct04456595).Based on the investigation alinity sars-cov-2 igg ii quant reagent lot 28453fn00 is performing as intended, no systemic issue or deficiency of the alinity sars-cov-2 igg ii quant reagent was identified.

• Brand Name: SARS-COV-2 IGG II QUANT REAGENT KIT
• Type of Device: SARS-COV-2 LGG
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 12314234
• MDR Text Key: 266247787
• Report Number: 3008344661-2021-00157
• 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: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Catalogue Number: 06S60-22
• Device Lot Number: 28453FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I1000SR MOD, 01L86-01, I1SR01826; ARC I1000SR MOD, 01L86-01, I1SR01826; ARC I1000SR MOD, 01L86-01, I1SR01826