MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGG

Catalog Number 30320

Device Problem False Negative Result (1225)

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

Event Type  malfunction  

Event Description

A customer from (b)(6) notified biomérieux of obtaining a false negative lyme result (124 rfv 0.12 negative c1) for a patient sample while using the vidas® lyme igg 60 tests (reference 30320, lot 1007253140).This initial sample was tested in automatic mode and was re-run in manual mode.The manual retest also yielded a negative result.The sample was also tested using vidas lyme igm, diasorin liaison®, and western blot test methods.A positive result was obtained for all assays.There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health.Biomérieux has initiated an internal investigation.Note: reference 30320 is not registered in the united states.The u.S.Similar device is product reference 417401 (vidas lyme igg ii).

Manufacturer Narrative

An internal investigation was performed for a customer report of obtaining a false negative lyme result (124 rfv 0.12 negative c1) for a patient sample while using the vidas® lyme igg 60 tests (reference 30320, lot 1007253140).This initial sample was tested in automatic mode and was re-run in manual mode.The manual retest also yielded a negative result.The sample was also tested using vidas lyme igm, diasorin liaison®, and western blot test methods.A positive result was obtained for all assays.Note: reference 30320 is not registered in the united states.The u.S.Similar device is product reference 417401 (vidas lyme igg ii).The customer submitted the sample for the investigation.--- batch history and trend analysis --- the analysis of the batch history records for vidas lyg (lyme igg) lot 1007253140/ 200324-0, showed no anomaly during the manufacturing, control and packaging processes.There is no capa (corrective action preventive action) and no-non conformity recorded on vidas lyg linked to the customer's issue.--- study of internal sample control charts --- investigational testing included testing seven internal samples (three high positive - target : 3.70-3.71-4.00 tv, three low positive - target : 0.27-0.35-0.79 tv and one negative) on six different batches of vidas lyg including the customer's lot 1007253140/ 200324-0.The analysis of the control charts showed that all results are within specifications.The customer's lot 1007253140/ 200324-0 is in the trend of the other lots.--- internal and customer sample results --- - internal samples: tests were conducted with four internal samples (three positive - target : 0.27 - 0.79 - 0.35 tv and one negative) with the retain kit vidas lyg lot 1007253140/ 200324-0 all internal samples results were within specifications and similar to those obtained before the batch release.There was no drift of the batch since its release.- customer samples: the complaint laboratory received a retuned tube with 1 ml of sera (orange and not clear) of the customer's sample.The complaint laboratory tested the returned sample, with the retain kit vidas lyg lot 1007253140/ 200324-0.The result obtained tv 0.14 is negative, result similar to those obtained by the client (tv 0.10 and 0.12).--- conclusion --- according to the investigation and customer's results, there was no reconsideration of the performance of the lot vidas lyg 1007253140/ 200324-0.The design between the vidas lyg and the additional testing methods the customer performed on this patient's sample is different, which could explain this discrepancy.

• 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: 9176824
• MDR Text Key: 196127984
• Report Number: 8020790-2019-00060
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2020
• Device Catalogue Number: 30320
• Device Lot Number: 1007253140
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1