VIDAS? TOXO IGG II 30210

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-07-14 for VIDAS? TOXO IGG II 30210 manufactured by Biomerieux Sa.

Event Text Entries

[49568269] A customer in (b)(6) notified biomerieux regarding discrepant results with the vidas toxo igg ii test kit (reference 30210) the customer reports that two samples were previously tested by a laboratory where the pure sample was tested at dilutions of 1/5 and 1/10; these results, per the customer, demonstrated that the performance did not produce an acceptable level of linearity. The customer reports testing previous samples on a new batch of product using a new vidasinstrument; this testing resulted in a confirmation of the previous non-linear results. In this incident, the customer reported the death of a patient related to congenital toxoplasmosis; however, the physician indicated the death was not related to results obtained by the vidasoxo igg ii, but instead related to underlying problems the patient had. An internal biomerieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5

[55006065] This report was initially submitted following notification that a customer in (b)(6) reported discrepant avidity results in association with the vidas toxo igg (txg) ii assay. Biom? Rieux investigation was conducted. The issue can occur when it is necessary to bring the sample titer to 15 ui/ml, as stated in package insert of vidas toxo igg avidity. Evaluation of the manufacturing batch record for the referenced lot indicated no anomaly or nonconformity associated with the batch. Internal testing demonstrated that: there is no issue with the sensitivity nor the specificity of the test. The vidas toxo igg ii is within the expected performance claimed in the package insert. In the vidas toxo igg ii application, some high titer samples may be underestimated when diluted but there is no risk of false negative results. In the vidas toxo igg avidity application, the vidas system will display "invalid results" if the sample dilution is not optimal, but there is no risk of false avidity results. The investigation concluded the performance of vidas txg ii assay is within specifications.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3002769706-2016-00117
• MDR Report Key: 5795347
• Report Source: COMPANY REPRESENTATIVE,FOREIG
• Date Received: 2016-07-14
• Date of Report: 2016-06-27
• Date Mfgr Received: 2016-06-27
• Date Added to Maude: 2016-07-14
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. JONATHAN NONNEMACHER
• Manufacturer Street: 100 RODOLPHE STREET
• Manufacturer City: DURHAM NC 27712
• Manufacturer Country: US
• Manufacturer Postal: 27712
• Manufacturer Phone: 9196203396
• Manufacturer G1: BIOMERIEUX SA
• Manufacturer Street: CHEMIN DE L ORME
• Manufacturer City: MARCY L ETOILE, RHONE 69280
• Manufacturer Country: FR
• Manufacturer Postal Code: 69280
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: VIDAS? TOXO IGG II
• Generic Name: VIDAS? TOXO IGG II
• Product Code: GLZ
• Date Received: 2016-07-14
• Catalog Number: 30210
• Lot Number: 1004465080
• Device Expiration Date: 2016-09-08
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Eval'ed by Mfgr: N
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: BIOMERIEUX SA
• Manufacturer Address: CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280

Device Sequence Number: 1

• Brand Name: VIDAS? TOXO IGG II
• Generic Name: VIDAS? TOXO IGG II
• Product Code: CHP
• Date Received: 2016-07-14
• Catalog Number: 30210
• Lot Number: 1004465080
• Device Expiration Date: 2016-09-08
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BIOMERIEUX SA
• Manufacturer Address: CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2016-07-14