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 ((b)(6)).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 (b)(6) 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 (b)(6): vidas result = 0.14 (negative interpretation).Reference lab result = 1.50 (positive interpretation).Rapid test: positive.Sample (b)(6): vidas result = 0.82 (negative interpretation).Reference lab result = 2.71 (positive interpretation).Rapid test: positive.Sample (b)(6): vidas result = 0.58 (negative interpretation).Reference lab result = 3.02 (positive interpretation).Rapid test: positive.Sample (b)(6): vidas result = 0.24 (negative interpretation).Reference lab result = 5.28 (positive interpretation).Rapid test: positive.Sample (b)(6): 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
• Manufacturer (Section G): BIOMERIEUX SA; 376 chemin de l orme; marcy l etoile 69280 ; FR 69280
• Manufacturer Contact: danielle cooper ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 11386887
• MDR Text Key: 269878446
• Report Number: 8020790-2021-00019
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: UNCLASSIFIED
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1