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U.S. Department of Health and Human Services

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

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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 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.
 
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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 Key9649682
MDR Text Key207751633
Report Number8020790-2020-00010
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 04/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/21/2020
Device Model Number417401
Device Catalogue Number417401
Device Lot Number1007326720
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 Received03/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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