MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGG

Catalog Number 30320

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2018

Event Type  malfunction  

Event Description

A customer in (b)(6) reported false negative results in association with the vidas® lyme igg assay ( lot 1006571330).On (b)(6) 2018, the customer received a cerebrospinal fluid (csf) sample to test for neuroborreliosis.They also asked the neurologist for serum (blood) to test for intrathecal igg synthesis.The vidas lyme igg test was performed on both samples (csf and blood), and both results were negative.The blood sample was negative with an index at 0.15, and the csf sample had an index at -0.02, with intrathecal igg antibody production index (iap) obtained at 0.The csf did not indicate any sign of inflammation (normal number of lymphocytes, normal total protein).Therefore the customer concluded that there was no intrathecal synthesis of lyme igg antibodies.The neurologist then sent the samples to a private laboratory: both samples were positive twice with the liaison® vlse (variable major protein-like sequence expressed) method.The first sample was obtained at 20 au/ml and the consecutive sample was obtained at 40 au/ml (positive as off 10-15 au/ml).The customer also tested the sample with vidas lyme igm and the result was positive.A western blot assay was performed for both igg and igm, and both were positive.There is no indication or report from the hospital or treating physician to biomérieux 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 in response to a report from a customer in belgium regarding false negative results in association with the vidas® lyme igg assay (lot 1006571330).Internal biomérieux investigation was conducted.Evaluation of the manufacturing batch records for vidas® lyme igg assay lot 1006571330 showed no anomaly during the manufacturing, control and packaging processes.All the results were within acceptable ranges and vidas lyg batch 1006571330 is compliant to the product specifications.Investigational testing included: internal samples: 6 samples panel were tested on vidas lyme igg 1006571330.All the samples were within their specifications and didn't show any evolution over time of vidas lyme igg batch 1006571330 activity since its release.Internal quality control sample: a sample of accurun 130 was tested on vidas lyme igg batch 1006571330, and a positive result was obtained as expected.Patient sample: the patient sample was found negative on vidas lyme igg batch 1006571330 with an index= 0.5 tv (positive threshold >=0.20 tv).This sample was tested by biomnis (external laboratory) using mikrogen igg western blot method; presence only of a nonspecific band (antip41) leading to a negative score.Biomnis concluded to absence of igg antibodies against borrelia in the serum.Moreover, an antibiotic therapy has been undergone on (b)(6) 2018 and this could explain the weak kinetic of the igg antibodies.In vidas lyme igg ref.30320 package insert, it is mentioned at section limitations of the method: "patients in the early stages of infection or who have undergone an antibiotic therapy, may not produce measurable igm and igg.Patients with clinical history and/or symptoms suggestive of lyme borreliosis but with negative test results should be reported as no detectable antibodies to b.Burgdoferi.A second specimen should be collected 4-6 weeks later." additionally, in the section performance, the sensitivity claimed is as follows (results coming from 2 study): for erythema migrans stage : the sensitivity is between 51% [ic 95 : 36.3-65.6] and 58.2% [ic95 : 44.1-71.4].For neuroborreliosis : 90.0% [ic 95 : 79.5-96.2] and 91.4% [ic 95 : 82.3-96.8].For arthritis/ accrodermatitis : 100.0% [ic 95 : 92.5-100.0] and 96.1% [ic 95 : 86.5-99.5].The investigation concluded that the vidas® lyme igg assay ( lot 1006571330) is performing as intended.

• Brand Name: VIDAS® LYME IGG
• Type of Device: VIDAS® LYME IGG
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• MDR Report Key: 8065985
• MDR Text Key: 129161818
• Report Number: 3002769706-2018-00238
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: 30320
• Device Lot Number: 1006571330
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1