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  

Manufacturer Narrative

A biomérieux internal investigation has been completed with the following results: -the analysis of the batch history record of vidas sars cov-2 igg lot 1008244900 / 210729-0 showed no anomaly during the manufacturing, control and packaging processes.- an analysis was performed on multiple positive sera from internal serum libraries using seven (7) lots of vidas sars cov igg, including the customer lot (lot 210729-0).All values are were within their specifications and customer lot (lot 210729-0) was in line with the other lots.-the investigation unit laboratory tested three (3) positive samples and one (1) negative sample of sars-cov-2 igg from the qc serum library (serothèque).All were tested on the retain kits of sars-cov-2 igg kit (lot 210729-0, customer lot).The results of the calibration complied with the mle data for the batch.The results for negative and positive sera were compliant and there was no drift observed with sars-cov-2 igg kit (lot 210729-0, customer lot).-the customer anomaly was not reproduced.-unfortunately, without any of the concerned samples available, further investigations cannot be performed.-per the investigation, vidas® sars-cov-2 igg kit (reference 423834 batch 1008244900 / 210729-0) is still within specifications.

Event Description

Biomerieux was notified that the issue initially reported in medwatch 8020790-2020-00138 impacted a total of five patients.Therefore, four additional medwatch forms are being submitted.A customer in spain notified biomérieux of obtaining potential false negative results while testing patient samples using the vidas® sars-cov-2 igg (ref 423834, batch 1008244900, expiry date 29-jul-2021).The customer reported the following results: - sample 1: vidas result = 0.14 (negative interpretation) reference lab result = 1.50 (positive interpretation) rapid test: positive.- sample 2: vidas result = 0.82 (negative interpretation) reference lab result = 2.71 (positive interpretation) rapid test: positive.- sample 3: vidas result = 0.58 (negative interpretation) reference lab result = 3.02 (positive interpretation) rapid test: positive.- sample 4: vidas result = 0.24 (negative interpretation) reference lab result = 5.28 (positive interpretation) rapid test: positive.-sample 5: vidas® sars-cov-2 igg (negative) vidas® sars-cov-2 igm (positive) rapid test: positive.There is no indication or report from the laboratory that the discrepant results led to any adverse event related to the patient's state of health.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.

• 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
• MDR Report Key: 11386912
• MDR Text Key: 280448500
• Report Number: 8020790-2021-00017
• 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
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2021
• Device Catalogue Number: 423834
• Device Lot Number: 1008244900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1