MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGM

Catalog Number 30319

Device Problem False Negative Result (1225)

Patient Problem Misdiagnosis (2159)

Event Type  malfunction  

Event Description

A customer in the (b)(6) notified biomérieux of discrepant results associated with vidas® lyme igm (reference 30319).The customer reported having a recent patient sample that flagged igg positive and igm negative on the initial screening with vidas®.The sample was sent to a reference laboratory and the result was positive for both igg and igm.The reference laboratory borrelia igm lineblot indicated antibody to osp17 antigen to be detected.Patient treatment was delayed resulting in further issues.A biomérieux investigation will be initiated.

Manufacturer Narrative

This report was initially submitted in response to a customer in (b)(6) reporting discrepant results associated with vidas® lyme igm (reference 30319).The customer reported having a recent patient sample that flagged igg positive and igm negative on the initial screening with vidas®.The sample was sent to a reference laboratory and the result was positive for both igg and igm.The reference laboratory borrelia igm lineblot indicated antibody to osp17 antigen to be detected.An internal investigation was conducted.Evaluation of the batch history records indicated the vidas lyme igm lot 1005460450/171212-0 showed no anomaly during the manufacturing and control processes.Control charts of 12 internal samples (7 positive, 4 equivocal, 1 negative) on 6 vidas lyme igm batches (including lots mentioned by customer) showed that all the results are within specifications.Vidas lyme igm lot 1005460450/171212-0 is in the trend of other batches.Five internal samples were tested (3 positive, 1 equivocal and 1 negative) on the retain kit vidas lyme igm lot 1005460450/171212-0.The results obtained were within the expected specifications and similar to those obtained during release.As the customer did not comply with biomérieux's request for the patient isolate, no further investigation is possible.The investigation concluded the vidas lyme igm assay is performing as intended.

• Brand Name: VIDAS® LYME IGM
• Type of Device: VIDAS® LYME IGM
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280; FR
• MDR Report Key: 7083102
• MDR Text Key: 93735482
• Report Number: 3002769706-2017-00392
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• PMA/PMN Number: K122979
• 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: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/12/2017
• Device Catalogue Number: 30319
• Device Lot Number: 1005460450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention