MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGG II 60 TESTS

Model Number 417401

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

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

Event Type  malfunction  

Event Description

A customer in the united states notified biomérieux of obtaining a false negative result for a patient sample in association with the vidas® lyme igg 60 tests (ref 417401, lot 1007326720).The customer tested the patient sample using vidas® lyme igg 60 tests which obtained a result of negative.The customer also tested the sample using line blot and sofia test method, both assays yielded a result of positive for both samples.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.Biomérieux will initiate an internal investigation.

Manufacturer Narrative

An investigation was initiated in response to a customer complaint of a false negative result for a patient sample in association with the vidas® lyme igg 60 tests (ref 417401, lot 1007326720).The customer was unable to submit the sample for investigational testing.There have been no other complaints registered for this type of issue for this lot.An internal study was conducted with internal samples on 13 different batches of vidas® lyme igg, including the customers lot (1007326720).The analysis of the control charts showed that all results were within specifications, customer¿s lot was in the trend of the other lots.Two (2) negative samples and three (3) positive samples were tested on lot 1007326720 all results were compliant to specifications.Without the customer's sample, no root cause was able to be established.The internal study did not identify any issue with the customer's lot of vidas® lyme igg 60 tests (ref 417401, lot 1007326720).See h10 for addtl mfg narrative.

• Brand Name: VIDAS® LYME IGG II 60 TESTS
• Type of Device: VIDAS® LYME IGG II 60 TESTS
• Manufacturer (Section D): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• MDR Report Key: 9649657
• MDR Text Key: 207751490
• Report Number: 8020790-2020-00009
• Device Sequence Number: 1
• Product Code: LSR
• UDI-Device Identifier: 03573026458270
• UDI-Public: 03573026458270
• Combination Product (y/n): N
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2020
• Device Model Number: 417401
• Device Catalogue Number: 417401
• Device Lot Number: 1007326720
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1