MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® SARS-COV-2 IGG

Catalog Number 423834

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

On (b)(6) 2021, a customer from (b)(6) notified biomérieux of obtaining negative results when testing vaccinated patients with the vidas® sars-cov-2 igg assay ref.423834, lot 1008389800, expiry 26-oct-2021.The customer was comparing test results between different methods for vaccinated patients.The samples were collected on vaccinated people who received the second injection of astrazenca vaccine approximately two weeks ago.Some samples gave discrepant results compared to the results observed using roche method (vidas negative versus roche positive) patient 1: vidas sars cov-2 igg index= 0.67 tv (negative) roche 13.95 (positive).Patient 2: vidas sars cov-2 igg index= 0.48 tv (negative) roche 19.15 (positive).It should be noted that roche method provides a global response including iga, igm and igg detection and after vaccination, patients could also have igm antibodies.It was not specified if igm testing was performed.At the time of this assessment, there was no information provided regarding further clinical context of the two patients.There is no indication or report from the laboratory that the potential discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.Note: reference 423834 is not sold or distributed in the united states.However, u.S-only product reference, 423834-01, has the same formulation and physical properties as reference 423834.

Manufacturer Narrative

An internal investigation was initiated following notice from a customer in morocco of obtaining negative results when testing two vaccinated patients with the vidas® sars-cov-2 igg assay (ref.423834, lot 1008389800, expiry 26-oct-2021).For the two (2) samples, there was a positive interpretation using cobas roche anti sars cov-2 s (global antibodies detection).The customer confirmed that none of the patient samples had material left available to submit for the investigation.Investigations.Quality control records.Analysis of the lot history record did not show any discrepancies during the manufacturing, control or packaging processes on vidas sars cov-2 igg lot 1008389800.There are neither capas nor non-conformities recorded on this vidas assay that can be linked with the customer's issue.Control chart analysis.Control chart analysis was carried out for five (5) internal samples (3 with a positive target and 2 with a negative one), using seven (7) batches of vidas sars cov-2 igg including the lot mentioned by customer (1008389800).The analysis showed that the samples comply with the expectations and vidas sars cov-2 igg batch 1008389800 is consistent with its results as compared to the other lots.Test on internal samples.Our complaints laboratory tested four (4) internal samples (3 with a positive target and 1 with a negative target) on vidas sars cov-2 igg lot 1008389800 and a recent lot for reference (100863079).The samples results comply with the expected specifications for both lots, with no significant difference between them.Moreover, biomérieux did not observe any difference compared to the results observed before the batches release; no observation of any evolution over time of vidas sars cov-2 igg batch 1008389800.Conclusion.Biomérieux did not reproduce the vidas sars cov-2 igg negative result when testing positive internal samples on vidas sars cov-2 igg batch 1008389800.All of the results comply with expectations.Without any concerned sample available, further investigation could not be pursued.The cobas roche anti sars cov-2 s assay is based on a total antibodies detection including iga, igm and igg antibodies while vidas sars cov-2 igg is designed to detect only igg antibodies against sars cov-2.The hypothesis is that the discrepancy of results between vidas and roche method is linked to the serological profile of these samples, namely the presence of different classes of antibodies (iga, igm, igg) with different targets (spike antigen, rbd.).The package insert for vidas sars cov-2 igg (ref.423834), in the section limitations of the method, documents: ¿results obtained using samples from sars-cov-2 infected patients must be interpreted with caution.The individual immune response following sars-cov-2 infection varies considerably and might give different results with assays from different manufacturers.Results of assays from different manufacturers should not be used interchangeably.¿.According to the data mentioned above, there is no reconsideration of the performance of vidas sars cov-2 igg ref.423834 lot 1008389800.

• Brand Name: VIDAS® SARS-COV-2 IGG
• Type of Device: VIDAS® SARS-COV-2 IGG
• Manufacturer (Section D): BIOMERIEUX SA; 376 chemin de l'orme; marcy l¿etoile 69280 ; FR 69280
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l¿orme; marcy l¿etoile 69280 ; FR 69280
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 12337205
• MDR Text Key: 267100968
• Report Number: 8020790-2021-00175
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: MO
• PMA/PMN Number: UNCLASSIFIED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2021
• Device Catalogue Number: 423834
• Device Lot Number: 1008389800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1