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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
On (b)(6) 2018, a customer in (b)(6) reported false negative results when using the vidas® lyme igg assay, lot 1006571330. The customer stated they obtained vidas® lyme igg assay negative results for a (b)(6) year-old male patient 's samples with the impacted lot when performing repeat testing in (b)(6) 2018. The customer sent the patient samples to two external laboratories, and the results were positive. There is no indication or report from the hospital or treating physician to biomérieux that the discrepant result led to any adverse event related to the patient's state of health. A biomérieux internal investigation will be initiated.
 
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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
candace martin
595 anglum road
hazelwood, MO 63042
MDR Report Key8214200
MDR Text Key132782904
Report Number8020790-2019-00001
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 03/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/30/2019
Device Catalogue Number30320
Device Lot Number1006571330
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 Received02/21/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2018
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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