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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® TOXO IGM

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BIOMERIEUX SA VIDAS® TOXO IGM Back to Search Results
Catalog Number 30202
Device Problem False Negative Result (1225)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
A customer in (b)(6) notified biomérieux of obtaining a false negative result from a single patient in association with the vidas® toxo igm 60 tests (reference 30202, lot 1006329540) specifically the test strip lot 181210-0. The customer stated the patient tested positive for toxoplasma when tested with vidas ® toxo igg and western blot assays. The customer confirmed the incorrect results were reported to the treating physician, but did not result in any patient harm or mistreatment. A biomérieux internal investigation has been initiated. Note: reference 30202 is not registered in the united states. The u. S. Similar device is product reference 30202-01 (vidas toxo igm).
 
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Brand NameVIDAS® TOXO IGM
Type of DeviceVIDAS® TOXO IGM
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
3145068201
MDR Report Key8935348
MDR Text Key209793864
Report Number8020790-2019-00048
Device Sequence Number1
Product Code LSR
Combination Product (y/n)N
Reporter Country CodeAU
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 11/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/10/2018
Device Catalogue Number30202
Device Lot Number1006329540
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 Received10/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/05/2018
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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