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 Known Impact Or Consequence To Patient (2692)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = (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, that has a similar product distributed in the us, list number 06r86-20.

Event Description

The customer observed a false negative sars-cov-2 igg result for one patient on an architect i1000sr analyzer.The following data was provided (<1.4 index(s/c) is negative, >/=1.4 index(s/c) is positive): sample id (b)(6) initial result, on (b)(6) 2020, was 0.09 index(s/c).The sample was tested, on (b)(6) 2020, by abbott during a complaint investigation and the result was 2.31 index(s/c).There was no impact to patient management reported.

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.Device history record review on lot 19483fn00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.Tracking and trending reports were reviewed and did not identify any related trends.Sensitivity testing was done using an in-house retained kit of lot 19483fn00, stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lots are performing acceptably.The customer observed a negative result of 0.09 index when using architect sars-cov-2 igg, reagent lot 19483fn00.This did not align with testing performed on the returned patient sample through complaint (b)(4), which was initially logged to investigate potentially false positive architect sars-cov-2 igm results.The negative igg result of 0.09 index was not questioned at the time.Testing of the returned patient sample ((b)(6)) gave a positive igg result of 2.31 index.Additional testing using in process development assays for spike igg, total ig, and neutralizing nc-cbt ag nucleocapsid igg was performed on the sample with negative results obtained for spike igg and total ig.The sample was neutralized by adding nc-cbt ag to the sample indicating that the sample is potentially a true positive for sars-cov-2 igg.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.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.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, no systemic issue or deficiency of the architect sars-cov-2 igg reagent lot 19483fn00 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: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 11050201
• MDR Text Key: 251614000
• Report Number: 3008344661-2020-00140
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2021
• Device Catalogue Number: 06R86-22
• Device Lot Number: 19483FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1