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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 results from a single patient in association with the vidas® toxo igm 60 tests (reference 30202, lot 1006986180) specifically the test strip lot 1909210. The customer stated the patient was initially tested at sixteen weeks and again at eighteen weeks. The patient tested negative for toxo igm and positive for toxoplasma when tested with vidas ® toxo igg and isaga during both rounds of testing. 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 Key8935346
MDR Text Key218747018
Report Number8020790-2019-00049
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 Date09/21/2019
Device Catalogue Number30202
Device Lot Number1006986180
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 Manufactured12/11/2018
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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