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

On (b)(6) 2018, a customer in (b)(6) reported false negative results when using the vidas® lyme igg assay, lot 1006571330. The customer stated they obtained vidas® lyme igg assay negative results for a (b)(6) year-old male patient 's samples with the impacted lot when performing repeat testing in (b)(6) 2018. The customer sent the patient samples to two external laboratories, and the results 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.

• 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
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile, rhone 69280, ; FR
• Manufacturer Contact: candace martin ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 8214200
• MDR Text Key: 132782904
• Report Number: 8020790-2019-00001
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/30/2019
• Device Catalogue Number: 30320
• Device Lot Number: 1006571330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2018
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial