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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, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer from (b)(6) notified biomérieux of a misidentification associated with vitek® 2 gn test kit involving a patient sample. The customer reported the sample was taken from a toe and the vitek® 2 gn test kit identified the organism as citrobacter youngae. The second result was citrobacter amalonaticus (91%). As the indole was positive, they decided for citrobacter amalonaticus. In addition, the customer indicated the vitek® ms identified the organism as citrobacter freundii and enterobacter aerogenes. The second run was citrobacter freundii. They provided the final result as citrobacter amalonaticus. The customer indicated patient results were affected, the patient was not harmed or mistreated; however, there was a delay of greater than 24 hours. In addition, the customer indicated it was unknown as to whether an incorrect result was reported to the physician as the correct result was unknown at that time. An internal biomérieux investigation will be initiated.
 
Manufacturer Narrative
This report was initially submitted due to a misidentification of citrobacter murliniae as citrobacter youngae or citrobacter amalonaticus in association with the vitek® 2 gn id test kit. An internal biomérieux investigation was performed. Investigational testing included: - 16s sequencing: obtained an identification to citrobacter murliniae. - vitek® 2 gn id (customer lot and random lot): both lots obtained a low discrimination between citrobacter youngae and citrobacter amalonaticus. Citrobacter murliniae is not in the vitek® 2 gn knowledge base. The vitek® 2 product information manual indicates which organisms can be identified using the vitek® 2 gn id card; citrobacter murliniae is not listed. The vitek® 2 gn id instructions for use (product information manual) state "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. " for any organism placed into a test card, the vitek® 2 system will assess the card readings against the known organisms and provide an organism identification, if possible, based on a combination of growth well reactions. For results with a percent confidence of <99%, the customer must make a determination of acceptance or further testing based on the logical likelihood of the identification considering other laboratory and clinical factors. - vitek® ms: citrobacter werkmanii citrobacter murliniae is not in the vitek® ms knowledge base. - api® 50 che v3: after 24 hours citrobacter freundii 99,7% good identification; after 48 and 72 hours doubtul profile between citrobacter amalonaticus and pantoea spp 2 citrobacter murliniae is not in the api® knowledge base. The investigation concluded the vitek® 2 gn id test kit is performing as intended and as described in labeling.
 
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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
st. louis MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC
595 anglum road
st. louis MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
hazelwood, MO 63042
3147317301
MDR Report Key6121038
MDR Text Key60691313
Report Number1950204-2016-00191
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
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 03/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/01/2017
Device Catalogue Number21341
Device Lot Number241385210
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 Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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