MAUDE Adverse Event Report: BIOMERIEUX SA VIDAS® TOXO IGM

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 1006817550) specifically the test strip lot 1907140. The customer stated the patient tested positive for toxoplasma when tested with vidas ® toxo igg, toxo isaga 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).

• Brand Name: VIDAS® TOXO IGM
• Type of Device: VIDAS® 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 Key: 8935345
• MDR Text Key: 209796395
• Report Number: 8020790-2019-00045
• Device Sequence Number: 1
• Product Code: LSR
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K141133
• Number of Events Reported: 1
• 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,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 07/14/2019
• Device Catalogue Number: 30202
• Device Lot Number: 1006817550
• 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 Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2018
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial