MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD

Catalog Number 21341

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

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

Event Type  malfunction  

Manufacturer Narrative

Device not returned to manufacturer.

Event Description

A customer in the united states reported the vitek 2 gram-negative (gn) id test kit misidentified a urine sample as klebsiella pneumoniae. The isolate was sent to a state lab because of possible cre (carbapenem-resistant enterobacteriaceae). A result of enterobacter aerogenes was obtained via maldi method. Upon receiving the discrepant maldi result as compared to the vitek 2 gn id result, the customer performed testing of the isolate via apitrip; the result was enterobacter aerogenes. Retesting using the vitek 2 gn id card again provided the identification of klebsiella pneumoniae. The customer indicated the isolate was mucoid but still went into a homogenous suspension. Biomerieux has requested submittal of patient isolate for internal testing. There is no indication or report from the hospital or treating physician to biomerieux that the organism misidentification led to any adverse event related to the patient's state of health. An internal biomerieux investigation will be initiated.

Manufacturer Narrative

Biomérieux internal investigation was conducted. Testing included one (1) vitek® 2 gn id card from a lot manufactured close to the lot used by the customer and one (1) card from a random lot. Api® 20e test was also performed. The vitek® 2 gn id cards provided organism identification of klebsiella pneumoniae, matching the customer result. The api® 20e gave an identification of enterobacter aerogenes. The investigation concluded that the patient isolate is an atypical strain for the vitek® 2 system phenotypic ast testing method. Genetic measurement techniques and non-automated methods such as api® and disc diffusion are more conducive to testing organisms exhibiting this behavior.

• Brand Name: VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
• Type of Device: VITEK® 2 GN ID 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: 5361529
• MDR Text Key: 35734621
• Report Number: 1950204-2016-00006
• Device Sequence Number: 1
• Product Code: JTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CL. I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/30/2015

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/23/2016
• Device Catalogue Number: 21341
• Device Lot Number: 241357140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial