MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT; VITEK® 2 ANC CARD

Catalog Number 21347

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in (b)(6) reported a discrepant organism identification on the vitek 2 anc test kit ((b)(4)) while testing an (b)(6) 15bac1 organism (aerococcus urinae).The customer reported corynebacterium amycolatum.There is no indication or report from the hospital to biomerieux that the discrepant result led to any adverse event related to a patient's state of health.The (b)(6) proficiency sample was not directly associated with any patient.Culture submittal has been requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux internal investigation was conducted.The submitted customer strain was tested via 16s sequencing, vitek® 2 anc test kit and vitek® 2 gp test kit (recommended for gram positive cocci).16s sequencing confirmed correct identification to the species aerococcus urinae.Vitek® 2 anc test kit provided a result of "unidentified organism".Vitek® 2 gp test kit provided correct identification to the species aerococcus urinae.The investigation did not duplicate the customer misidentification to the species corynebacteruim amycolatum.As indicated in the vitek® 2 system product information: the vitek® 2 anaerobic and corynebacteria (anc) identification test kit is intended for use with vitek® 2 systems for the automated identification of most clinically significant anaerobic organisms and corynebacterium species.The species aerococcus urinae is not included in the knowledge base of species identified using the vitek® 2 anc test kit.This species belongs to the vitek® 2 gp id knowledge base.Based on the investigation results, the vitek® 2 anc test kit is performing in accordance with product specifications.

• Brand Name: VITEK® 2 ANAEROBIC AND CORYNEBACTERIA IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 ANC CARD
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ryan lemelle ; 595 anglum road; hazelwood, MO 63042 ; 3147318582
• MDR Report Key: 5134950
• MDR Text Key: 27810006
• Report Number: 1950204-2015-00061
• Device Sequence Number: 1
• Product Code: JSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K910666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/25/2016
• Device Catalogue Number: 21347
• Device Lot Number: 244345010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1