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U.S. Department of Health and Human Services

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

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BIOMERIEUX SA VIDAS® LYME IGM II 60 TESTS Back to Search Results
Model Number 416436
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 patient sample in association with the vidas® lyme igm 60 tests (ref 416436, lot number not specified). The customer tested the patient sample using vidas® lyme igm 60 tests which obtained a negative result. The customer also tested the sample using western blot and sofia test method, both assays yielded a positive result. There is no indication or report from the laboratory that the discrepant result 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 IGM II 60 TESTS
Type of DeviceVIDAS® LYME IGM 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 Key9652884
MDR Text Key207751830
Report Number8020790-2020-00011
Device Sequence Number1
Product Code LSR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122979
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 Received01/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number416436
Device Catalogue Number416436
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
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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