MAUDE Adverse Event Report: BIOMERIEUX INC. VITEK® 2 GN TEST KIT; VITEK® 2 GN TEST CARD

Catalog Number 21341

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer in (b)(6) reported to biomérieux a misidentification of herbaspirillum hutiense as burkholderia cepacia in association with the vitek® 2 gn test kit.Repeat testing of the isolate gave the result of acinetobacter lwoffii.The customer tested the isolate using the bruker maldi method and received a result of herbaspirillum hutiense.The customer reported a delay of greater than 24 hours due to multiple retests.The customer provided the identification result as nonfermenters to the physician as no preliminary result was reported.There was no impact to the patient's health or treatment.Herbaspirillum hutiense is a limitation of the knowledge base for vitek® 2 identifications.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

A customer reported a misidentification of herbaspirillum huttiense as burkholderia cepacia in association with the vitek® 2 gn test kit (lot # 241386240).A repeat test provided a result of acinetobacter lwoffi.A biomérieux investigation was conducted.The sequencing result of the customer isolate is in favor to the species herbaspirillum huttiense (100%).The organism was subcultured on cba (columbia blood agar) and tested on three (3 ) gn id cards (1 customer lot 241386240 + 2 random lots).The results obtained on the three cards were a slashline burkholderia cepacia group.The investigation did not reproduce the misidentification to acinetobacter iwofii but reproduced the misidentification of burkholderia cepacia group (species very close).The species herbaspirillum huttiense is not in the knowledge base of vitek® 2 (v7.01).The vitek® 2 product information manual states the following for gram-negative identification: "newly described or rare species may not be included in the gn database.Selected species will be added as strains become available.Testing of unclaimed species may result in an unidentified result or a misidentification." the investigation concluded the vitek® 2 gn id test kit performed as intended.

• Brand Name: VITEK® 2 GN TEST KIT
• Type of Device: VITEK® 2 GN TEST CARD
• Manufacturer (Section D): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 6170375
• MDR Text Key: 62384757
• Report Number: 1950204-2016-00201
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: C1, EXEMPT
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2017
• Device Catalogue Number: 21341
• Device Lot Number: 241386240
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1