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

Catalog Number 06S61-22

Device Problem False Negative Result (1225)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 06s61-22 (sars-cov-2 igg ii quant) that has a similar product distributed in the us, list number 06s61-20/-30 (advisedx sars-cov-2 igg ii), eua(b)(4).All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

In the article by perez catalan, ignacio, et al., ¿nirmatrelvir/ritonavir as a potential treatment for prolonged sars-cov-2 infection in immunocompromised patients¿ published by revista espanola de quimioterapia 35.6: 589-591.Sociedad espanola de quiminoterapia.(2022).The article noted false negative alinity i sars-cov-2 igg ii quant.Result compared to positive pcr results for a 68-year-old male patient diagnosed with diffuse large b-cell lymphoma in 2009.He has been in remission for 2 years and has been vaccinated with 3 doses of the pfizer-biontech (last dose (b)(6) 2021).On (b)(6) 2022, he presented with febrile symptoms and cough and was diagnosed with covid-19 by detection in nasopharyngeal exudate sample of sars-cov-2 rna by real-time pcr (diasorin).However, when tested with the alinity i sars-cov-2 igg ii quant.Generated negative results.On (b)(6) with symptoms still persistent the patient still had not developed igg against s protein and pcr was still positive.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false negative alinity i sars-cov-2 igg ii quant.Results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Data and information provided in the article were reviewed and support the complaint issue.A review of tracking and trending did not identify any related trends for the list number and complaint issue.A review of the device history records did not identify any non-conformances, potential non-conformances, or deviations associated with the list number and complaint issue.Labeling was reviewed and adequately addresses the issue under review.In this case, technical operations performed a review of the article.The publication documents potential false negative results using the alinity i sars-cov-2 igg ii (6s61) assay for an individual who was positive for covid by pcr and who had previously been vaccinated using the pfizer-bionttech vaccine.The individual was also negative for covid igm antibodies using the diasorin assay.However, the publication documents this individual as being immunosuppressed.The sars-cov-2 igg ii quant insert documents that the assay is to be used as an aid in the diagnosis of sars-cov-2 infection in conjunction with clinical presentation and other laboratory tests.The assay is also to be used as an aid in evaluating immune status of individuals with quantitative measurement of igg antibodies against the spike receptor-binding domain (rbd) of sars-cov-2.Results from the sars-cov-2 igg ii quant assay should not be used as the sole basis for diagnosis.However, the limitations of the assay documents that 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, a study was performed to estimate the positive percent agreement (ppa).The ppa = 15 days post-symptom onset is 99.35% (95 % ci 96.44, 99.97).Twenty-one (21) specimens from 7 immunocompromised patients were excluded from the study.When the results from these specimens were included, the ppa at = 15 days post-symptom onset was 97.01% (95% ci: 93.18, 98.71).Based on the investigation alinity i sars-cov-2 igg ii quant.List number 6s61 is performing as intended, no systemic issue or product deficiency of the alinity i sars-cov-2 ii quant.Reagent was identified.

Event Description

In the article by perez catalan, ignacio, et al., ¿nirmatrelvir/ritonavir as a potential treatment for prolonged sars-cov-2 infection in immunocompromised patients¿ published by revista espanola de quimioterapia 35.6: 589-591.Sociedad espanola de quiminoterapia.(2022).The article noted false negative alinity i sars-cov-2 igg ii quant.Result compared to positive pcr results for a 68-year-old male patient diagnosed with diffuse large b-cell lymphoma in 2009.He has been in remission for 2 years and has been vaccinated with 3 doses of the pfizer-biontech (last dose 11.27.21).On (b)(6) 2022, he presented with febrile symptoms and cough and was diagnosed with covid-19 by detection in nasopharyngeal exudate sample of sars-cov-2 rna by real-time pcr (diasorin).However, when tested with the alinity i sars-cov-2 igg ii quant.Generated negative results.On day 58 with symptoms still persistent the patient still had not developed igg against s protein and pcr was still positive.There was no impact to patient management reported.

• 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: 16513979
• MDR Text Key: 311490009
• Report Number: 3008344661-2023-00049
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06S61-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWND11; ALNTY I PROCESSING MODU, 03R65-01, 205UNKNOWND11
• Patient Age: 68 YR
• Patient Sex: Male