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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 Date 07/10/2019
Event Type  malfunction  
Event Description
A customer in france contacted biomérieux to report the occurrence of false negative patient results for a (b)(6)-year-old female patient in association with the vidas® lyme igg assay (ref. 30320). The customer tested two samples from the patient who presented with knee pain for a year. In (b)(6) 2018, she had a loss of sensitivity in the big toe of her left foot. In recent months she has had a loss of sensitivity in her left calf and left cheek. In june, the patient experienced an episode of cephalalgia for one month and was treated with antibiotics. There was no evidence of a tick bite. The samples were tested with several methods and the results were discrepant: sample 1 (ref. 7142214) tested on (b)(6) 2019: vidas: negative result (value not reported). Liaison diasorin: positive result (igg
=
28 ua/ml). Western blot: positive result (value not reported). Sample 2 (ref. 4126342) tested on (b)(6) 2019: vidas: negative result (value not reported). Liaison diasorin: positive result (value not reported). Western blot: positive result (value not reported). Sample 2 (ref. 4126342) tested on (b)(6) 2019: vidas: negative result (rfv
=
0. 18). The samples were sent to the laboratory of "les hospices civils de lyon" and the results were the following: csf sample: liaison diasorin: negative result (value
=
0. 46). Serum sample: liaison diasorin: positive result (value
=
28. 75 ua/ml). There is no indication or report from the laboratory or a physician that the discrepant results led to any adverse event related to the patient's state of health. Biomérieux requested strain submittal from the customer. This event has been reviewed for vigilance reporting in accordance with 21 cfr 803, concerning medical device reporting. Biomérieux internal sop 016510 states a false negative result could have a negative influence on the treatment decision as treatment may be incorrectly withheld. This review has determined that this event meets the criteria for reporting as a malfunction. Although this event does not allege that death or serious injury actually occurred, it has been determined that there is potential for serious injury should the situation recur. A biomérieux internal investigation has been initiated. 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
jeff scanlan
595 anglum road
hazelwood, MO 63042
3147318694
MDR Report Key8915372
MDR Text Key208024914
Report Number8020790-2019-00041
Device Sequence Number1
Product Code LSR
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K122986
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 09/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2019
Is this an Adverse Event Report? No
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 Received08/30/2019
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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