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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

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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 contacted biomerieux to report a misidentification of escherichia coli as acinetobacter or aeromonas in association with the vitek 2 gn id test kit. The patient isolate was tested via vitek ms system providing a result of escherichia coli. Per laboratory guidelines, an indole test was performed; the indole test was negative so the customer tested further with the vitek 2 gn id test. The vitek 2 gn id card provided a result of acinetobacter haemolyticus. Upon investigation the laboratory technician re-subcultured the organism and re-identified via vitek 2 gn id card; the subsequent result was aeromonas sobria. The identification and ast results of aeromonas sobria were accepted and reported to physician's office. The next day the aeromonas identification was questioned. Plates were pulled and indole testing was repeated; the result was positive. The vitek ms testing was also repeated and again obtained an organism id of escherichia coli. The patient record was updated with the new results. There is no report from the hospital or treating physician that the occurrence lead to any adverse event related to the patient's state of health. Culture submittals were requested by biomerieux for internal investigation. An internal biomerieux investigation will be initiated.
 
Manufacturer Narrative
This report was initially submitted due to vitek 2 gn id misidentification of escherichia coli as acinetobacter or aeromonas. Biomérieux investigation was conducted following receipt of the patient isolate submitted by the customer. The isolate was subcultured and testing included two (2) gn id cards from the same lot tested by the customer, two (2) gn id cards from a random lot, the api 20e, and 16s sequencing. The two gn cards from the random lot and one card from the customer lot gave low discrimination calls of escherichia coli/aeromonas sobria. The second gn card from the customer lot gave a good identification of escherichia coli. The api 20e gave a low discrimination identification of escherichia coli/citrobacter koseri/farmerii. The 16s sequencing identified the isolate as escherichia coli. Review of the customer's aeromonas sobria data against expected reactions for escherichia coli demonstrated seven atypical negative reactions as well as one atypical positive reaction, contributing to the misidentification. The investigation concluded this is an atypical strain for the vitek 2 gn knowledge base.
 
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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
ellen weltmer
595 anglum road
hazelwood, MO 63042
3147317301
MDR Report Key5865447
MDR Text Key51937726
Report Number1950204-2016-00092
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 07/13/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/25/2017
Device Catalogue Number21341
Device Lot Number241378540
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 Received07/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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