• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMERIEUX, INC VITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT VITEK® 2 GN ID CARD Back to Search Results
Catalog Number 21341
Device Problem Incorrect, Inadequate or Imprecise Resultor 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVITEK® 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT
Type of DeviceVITEK® 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 Key5361529
MDR Text Key35734621
Report Number1950204-2016-00006
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
CL. I EXEMPT
Number of Events Reported1
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 Received01/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/23/2016
Device Catalogue Number21341
Device Lot Number241357140
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 Received12/30/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/24/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-