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) contacted biomerieux to report a discrepant (b)(6) organism identification on the vitek 2 anaerobic and corynebacteria (anc) identification (id) test kit.Corynebacterium ulcerans was misidentified as corynebacterium minutissinum.Upon retesting, the correct result of corynebacterium ulcerans was obtained.There is no indication or report from the hospital or treating physician to biomerieux that the discrepant result led to any adverse event related to any patient's state of health.No patient was directly associated with the abp survey result.Culture submittals have been requested by biomerieux for internal investigation.An internal biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux investigation was conducted.Investigational testing included: - vitek® 2 anc id cards (customer lot expired, so two random lots were tested) to check the customer result, - vitek® ms, - api® coryne strip.Results: - vitek® 2 anc id: excellent identification to corynebacterium ulcerans, for both lots tested.- vitek® ms: excellent identification to the species corynebacterium ulcerans.- api® coryne strip: doubtful profile with a possibility of corynebacterium minutissimum.The investigation did not reproduce the vitek® 2 anc id misidentification to the species corynebacterium minutissimum obtained by the customer.The investigation also determined the customer was sub-culturing to a non-recommended media.The customer retested with recommended media (cba) and obtained the correct result.The misidentification appears to be related to the use of non-recommended media by the customer.Based on the results of the investigation, the vitek® 2 anc id is performing as expected.

• 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: 5329407
• MDR Text Key: 34474215
• Report Number: 1950204-2015-00130
• 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: Initial,Followup
• Report Date: 12/02/2015

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: 01/06/2016
• Device Catalogue Number: 21347
• Device Lot Number: 244331010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2014
• 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