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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® LYME IGG

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BIOMERIEUX SA VIDAS® LYME IGG Back to Search Results
Catalog Number 30320
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer from (b)(6) notified biomérieux of obtaining a false negative lyme result (124 rfv 0. 12 negative c1) for a patient sample while using the vidas® lyme igg 60 tests (reference 30320, lot 1007253140). This initial sample was tested in automatic mode and was re-run in manual mode. The manual retest also yielded a negative result. The sample was also tested using vidas lyme igm, diasorin liaison®, and western blot test methods. A positive result was obtained for all assays. 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 has initiated an internal investigation. Note: reference 30320 is not registered in the united states. The u. S. Similar device is product reference 417401 (vidas lyme igg ii).
 
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Brand NameVIDAS® LYME IGG
Type of DeviceVIDAS® 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
danielle cooper
595 anglum road
hazelwood, MO 63042
3145068201
MDR Report Key9176824
MDR Text Key196127984
Report Number8020790-2019-00060
Device Sequence Number1
Product Code LSR
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K141133
Number of Events Reported1
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 12/05/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2019
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/24/2020
Device Catalogue Number30320
Device Lot Number1007253140
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 Received11/05/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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