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

Intended use: vidas® sars-cov-2 igg (9cog) is an automated qualitative assay for use on the vidas® family of instruments, for the detection of immunoglobulin g (igg) specific for sars-cov-2 in human serum or plasma (lithium heparin) using the elfa (enzyme linked fluorescent assay) technique.This assay is intended for use as an aid to determine if individuals may have been exposed and infected by this virus and if they have mounted a specific anti-sars-cov-2 igg immune response.Interpretation of results interpretation of results according to test value (i) is as follows: index interpretation, i < 1.00 negative, i = 1.00 positive.Description of the issue: on 04-nov-2021, a customer from (b)(6) notified biomérieux of obtaining potential discrepant results when using vidas® sars-cov-2 igg (9cog) 60t (ref.423834, lot unknown) for a proficiency sample (rcpa qap survey for coronavirus sars-cov-2 antibodies 2021).For qc sample se cov21-08: all the vidas users found a negative result for igm as expected and a negative result for igg while it was expected positive.No specific lot was mentioned for the vidas peer group but users tested the qc sample with - different lots with results between 0.47 and 0.67 tv.According to the report, the qc sample was not manufactured using a single donation but with a pool of serum.There is no patient associated with this proficiency sample; therefore, there is no adverse event related to any 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 performed following notification from a customer in new zealand of obtaining potential discrepant results when using vidas® sars-cov-2 igg (9cog) 60t (ref.423834, lot 1008366980) for a proficiency sample (rcpa qap survey for coronavirus sars-cov-2 antibodies 2021).Investigation: the analysis of the batch history record for the vidas sars-cov-2 igg ref.423834, lot 1008366980 showed no anomaly during the manufacturing, control, and packaging processes.Control chart analysis was conducted on four internal samples with a respective target between 1.34 and 2.23 tv, using seven lots of vidas sars cov-2 igg (including the customer¿s lot).All sample results complied with the specifications and results obtained from the customer¿s lot are consistent with the results from other lots.Testing: it was not possible to conduct tests on vidas sars cov-2 igg ref.423834, lot 1008366980 because the lot was already expired at the date of customer¿s complaint.However, during a previous investigation, the complaints laboratory tested three (3) internal positive samples and a negative one on vidas sars cov-2 igg ref.423834, lot 1008366980.All the results were compliant with the specifications with similar results as the ones observed before the batch release; indicating that the results have not drifted over time.Analysis of reports of external quality assessment programs: the complaints laboratory subscribes to external quality assessment programs and tests different quality control samples as an ordinary laboratory.According to the analysis of outcomes of those programs and investigation, there is no reconsideration of performances of any lot of vidas sars cov-2 igg ref.423834.Information from rcpaqap program: for sars-cov-2 igg and sars-cov-2 point of care igm, which may be related to variation in kit specificity and sensitivity or sample matrix effect (sample was pooled sera).For sars-cov-2 igg, most users reported similar results to their peers within their respective method groups.Conclusion: the complaints laboratory did not reproduce the customer¿s anomaly, namely a negative result when testing internal positive samples on vidas sars cov-2 igg ref.423834, lot 1008366980 during a previous investigation.No anomalies were observed and the root cause remains unknown.The customer¿s issue could be linked to the sample itself (profile, matrix effect, concentration of igg antibodies).However, the customer has not provided any of their sample to the complaints laboratory, thus further investigation cannot be pursued.The clsi guideline ep14-a3 states that processed samples used as qc material (e.G eqa) can have matrix effect - ¿current scientific data suggest that such use of pt/ eqa results is not always feasible because of matrix effects.These processed materials us as pt/ eqa samples sometimes do not behave like patient samples routinely analyzed in the laboratory.Biases not generally seen with fresh biological fluids, are frequently seen with pt / eqa samples.¿ according to the data mentioned above, there is no reconsideration of the vidas sars cov-2 igg ref.423834, lot 1008366980.

• 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: 12920122
• MDR Text Key: 289188726
• Report Number: 8020790-2021-00325
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Catalogue Number: 423834
• Device Lot Number: 1008366980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1