MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION 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 12/01/2023

Event Type  malfunction  

Event Description

A journal article by francisco llorente, elisa pérez-ramírez, mayte pérez-olmeda, desirée dafouz-bustos, jovita fernández-pinero, mercedes martínez-cortés, and miguel ángel jiménez-clavero.¿the detection of sars-cov-2 antibodies in an exposed human population is biased by the immunoassay used: implications in serosurveillance¿, pathogens 2023, 12, 1360.Documented false negative architect sars-cov-2 igg results that were positive by elisa eurofins and roche clia.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 6r86-22 that has a similar product distributed in the us, list number 6r86-20.

Manufacturer Narrative

The complaint investigation for false negative architect sars-cov-2 igg results included a search for similar complaints, review of the literature article, trending data, and labeling review.The review of complaints for the lot number was not performed as the lot was unknown.Trending review determined no trends for the issue for the product.Labeling was reviewed and found to adequately address the issue under review.The study referenced in the literature article (the detection of sars-cov-2 antibodies in an exposed human population is biased by the immunoassay used: implications in serosurveillance) used 668 serum samples from individuals in spain, collected during the first epidemic wave in april 2020.Out of these samples 93 were pcr positive before or on the day of sample collection (considered as ¿true positive¿ by the authors).A subset of these patients (115 samples that were positive by eurofins or idvet assays) were followed up at 2 and 7 months after initial sampling.The authors acknowledge a lack of a gold standard, so they used the eurofins elisa as reference for sensitivity and specificity calculations across all samples, however this is a total antibody kit detecting igm, igg and iga as opposed to the abbott kit which is igg specific.For follow up samples at 2 and 7 months, lower positivity was observed for the abbott assay, however once again, this was based on comparison to the ¿reference¿ assay which detects igg, igm and iga.In addition, the roche clia is also a total antibody assay, therefore direct comparison is not appropriate.The authors acknowledged that with sars-cov-2 infection, antibody levels can decline over time.Abbott updated the sars-cov-2 igg assay file to include an editable grayzone (0.49 to <1.40 s/co).This new grayzone would be applicable for those patients whose igg levels may be rising, i.E., during seroconversion, or may be declining, i.E., during seroreversion, with levels below the cutoff.In this study, the authors document the standard cut-off values recommended by the manufacturers were used.No specific result data were provided in this study, however, use of the grayzone may have improved detection of igg positivity further.Overall, assays of different formats (clia, lfa, elisa) and targets (nucleocapsid versus spike, total versus igg) were used in this study, making direct comparisons difficult, and the authors acknowledge that different aspects can affect sensitivity at different times post infections including isotype detected, antigen used and methodology of detection.Based on the investigation, the architect sars-cov-2 igg assay is performing as intended, no systemic issue or deficiency was identified.

Event Description

A journal article by francisco llorente, elisa pérez-ramírez, mayte pérez-olmeda, desirée dafouz-bustos, jovita fernández-pinero, mercedes martínez-cortés, and miguel ángel jiménez-clavero.¿the detection of sars-cov-2 antibodies in an exposed human population is biased by the immunoassay used: implications in serosurveillance¿, pathogens 2023, 12, 1360.Documented false negative architect sars-cov-2 igg results that were positive by elisa eurofins and roche clia.No impact to patient management was reported.

• Brand Name: SARS-COV-2-IGG REAGENT KIT
• Type of Device: REAGENT, CORONAVIRUS SEROLOGICAL
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18355334
• MDR Text Key: 331215428
• Report Number: 3008344661-2023-00199
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06R86-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• 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: ARC I2000SR INST, 03M74-02, SN# UNKNOWN; ARC I2000SR INST, 03M74-02, SN# UNKNOWN