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U.S. Department of Health and Human Services

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

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BIOMERIEUX INC. VITEK® 2 GN TEST KIT VITEK® 2 GN TEST CARD Back to Search Results
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.
 
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Brand NameVITEK® 2 GN TEST KIT
Type of DeviceVITEK® 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 Key6170375
MDR Text Key62384757
Report Number1950204-2016-00201
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
C1, EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/11/2017
Device Catalogue Number21341
Device Lot Number241386240
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2017
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

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