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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 in (b)(6) notified biomérieux of a misidentification associated with the vitek 2 gn test kit. The customer reported the vitek 2 gn test kit gave inadequate results of serratia fonticola instead of escherichia coli. The customer indicated performing a biochemical manual test as the alternate testing for identification. The customer indicated e. Coli results were reported out. An internal biomérieux investigation will be initiated.
 
Manufacturer Narrative
An investigation was conducted for a misidentification of escherichia coli as serratia fonticola in association with the vitek® 2 gn test kit. Information showed the customer was having identification issues with multiple species. Troubleshooting indicated that the customer prepared their own media, their saline may have been contaminated, and they did not test isolates at the appropriate age of culture. After the customer used prepared media from biomerieux, sterile saline, and an appropriate age of culture, all the identification issues ceased. Two lab reports were submitted for review. One lab report showed an excellent identification of serratia fonticola. There were four (4) atypical positive reactions (ado, ple, sac, dtag) against identification of e. Coli according to the gn knowledge base. The second lab report showed an excellent identification of e. Coli. A review of quality records confirmed gn lot 241390240 met final release criteria and there were no issues with initial performance testing an increased number of atypical positive reactions can indicate contamination, mixed culture, use of non-recommended media or other user set up errors or an atypical strain. However without the strain, or raw data it's not possible to further evaluate the cause of the misidentification.
 
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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 Key6120952
MDR Text Key60878253
Report Number1950204-2016-00190
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeCO
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 02/07/2017
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 Date03/24/2017
Device Catalogue Number21341
Device Lot Number241375320
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 Received01/10/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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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