• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMERIEUX SA VIDAS® LYME IGG II 60 TESTS Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVIDAS® LYME IGG II 60 TESTS
Type of DeviceVIDAS® 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 Key9920397
MDR Text Key207755310
Report Number8020790-2020-00039
Device Sequence Number1
Product Code LSR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141133
Number of Events Reported1
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 Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/26/2020
Device Model Number417401
Device Catalogue Number417401
Device Lot Number1007649070
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 Received04/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-