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

Model Number 417401

Device Problem Incorrect, Inadequate or Imprecise Resultor 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 false negative results for three patients when using vidas® lyme igg ii 60 tests (ref. 417401, lot 1007649070). For three patients, the customer obtained negative results when using vidas lyme igg ii 60 tests, lot 1007649070 with results respectively at 0. 02, 0. 03 and 0. 04. The same samples tested with western blot igg assay showed positive results. Sample (b)(6), rfv:28. ,tv: 0. 02, result:negative. Sample (b)(6), rfv:30, tv:0. 03, result: negative. Sample (b)(6): rfv , tv:0. 04, result negatvie. Western blot igg: sample (b)(6) positive. Sample (b)(6) positive. Sample (b)(6) positive. There is no indication or report from the laboratory that the false negative results led to any adverse event related to any patient's state of health.

• 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
• Manufacturer (Section G): BIOMERIEUX SA; chemin de l orme; marcy l etoile 69280 ; FR 69280
• Manufacturer Contact: matthew locus ; 595 anglum road; hazelwood, MO 63042 ; 3145068201
• MDR Report Key: 9920372
• MDR Text Key: 207754882
• Report Number: 8020790-2020-00037
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/26/2020
• Device Model Number: 417401
• Device Catalogue Number: 417401
• Device Lot Number: 1007649070
• 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: 04/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2019
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial