MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK 2 REAGENT

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A journal article from indonesia, "antifungal susceptibility testing in hiv/aids patients: a comparison between automated machine and manual method." was reviewed by biomérieux.The article indicated false susceptible results for voriconazole in association with vitek® 2 ast test kit(s).Test kit type(s) was not included in the article.There is no indication in the article, or any report from the laboratory associated with the article, that the discrepant result led to any adverse event related to a patient's state of health.An internal biomérieux investigation will be initiated.However, the strains use for testing are no longer available.

Manufacturer Narrative

A journal article from (b)(6), "antifungal susceptibility testing in (b)(6) patients: a comparison between automated machine and manual method." was reviewed by r&d.The article indicated false susceptible results for ampicillin and voriconazole in association with vitek® 2 ast test kit(s).Test kit type(s) was not included in the article.Further evaluation was requested.Strains, lab reports, product and lot numbers have been requested but are not available for investigation.Submittal of the isolate is required in order to confirm a vitek 2 discrepancy compared to reference method.Note that vitek 2 antifungals were developed compared to bmd.The reference method used in the study was clsi disk diffusion.Reported issue cannot be further investigated.Note: it was reported that this study was performed with vitek software version 04.01, suggesting the research was performed well before the 2016 publication date.

• Brand Name: VITEK 2 REAGENT
• Type of Device: VITEK 2 REAGENT
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: tiffany hall ; 100 rodolphe street; durham, NC 27712
• MDR Report Key: 7635002
• MDR Text Key: 112758340
• Report Number: 1950204-2018-00235
• Device Sequence Number: 1
• Product Code: NGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092454
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1