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

Catalog Number 423834

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of obtaining a false negative result while testing three (3) patient strains from separate patients using the vidas® sars-cov-2 igg test kit (reference # 423834, lot # 1008344690).The customer stated it was known that the patients had covid-19; however, the vidas® sars-cov-2 igg results were negative when compared to other methods.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.Vidas® sars-cov-2 igg: negative.Rt pcr: positive.Rapid test (igg):positive.The customer did not provide any additional details despite multiple attempts by customer service.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

This report was initially submitted following notification from a customer in morocco regarding false negative result while testing three (3) patient strains from separate patients using the vidas® sars-cov-2 igg test kit (reference # 423834, lot # 1008344690).The customer stated it was known that the patients had covid-19; however, the vidas® sars-cov-2 igg results were negative when compared to other methods.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.A biomérieux internal investigation has been completed with the following results: the customer did not have any remaining samples to be returned for investigation.According to quality control records, there is no anomaly highlighted during the manufacturing, control and packaging processes on vidas sars cov-2 igg lot 1008344690/210924-0.The complaints laboratory performed a control chart analysis on four (4) internal samples with a positive target.The samples were tested on seven (7) batches of vidas sars cov-2 igg including the lot mentioned by customer 1008344690/210924-0.The analysis showed that the samples complied with the expectations and vidas sars cov-2 igg batch 1008344690/210924-0 is in the trend compared to the other lots.The complaints laboratory performed a test on four (4) internal samples (3 with a positive target and 1 with a negative target).The sample results complied with the expected specifications without any significant difference compared to the results observed before the batch release.Therefore, no evolution was observed over time of vidas sars cov-2 igg batch 1008344690/210924-0.The customer's negative results were not reproduced on the vidas sars cov-2 igg when testing positive internal samples on vidas sars cov-2 igg batch 1008344690/210924-0.All the results complied with expectations.Without any concerned sample available, it was not possible to pursue further investigation.Therefore, a root cause was not determined.It is mentioned in the package insert of vidas sars cov-2 igg ref.423834 at the section limitations of the method: " - 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." the vidas sars cov-2 igg ref.423834 lot 1008344690/210924-0 is meeting its specifications.

• 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'étoile, 69280 ; FR 69280
• MDR Report Key: 11399770
• MDR Text Key: 234632741
• Report Number: 8020790-2021-00021
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• PMA/PMN Number: UNCLASSIFIED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Catalogue Number: 423834
• Device Lot Number: 1008344690
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1