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U.S. Department of Health and Human Services

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

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BIOMERIEUX, INC VITEK® 2 GN TEST KIT Back to Search Results
Catalog Number 21341
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
 
Event Description
A customer in united states notified biomerieux of a misidentification associated with the vitek 2 gn test kit (b)(4) involving a blood culture. The customer reported using the vitek 2 gn test kit that identified the organism as one of the shigella group. However, serology was positive for salmonella polyvalent antisera. The customer indicated there was no negative impact to the patient or adverse events.
 
Manufacturer Narrative
This report was initially submitted due to vitek® 2 gn id misidentification of salmonella ser paratyphi a as shigella group. Biomérieux investigation was conducted. Investigation details: the isolate was subcultured and testing included two (2) vitek 2 gn id cards from the same lot tested by the customer, two (2) cards from a random lot and api 20e. The four vitek 2 gn id cards gave excellent identification calls of escherichia coli. The api 20e provided identification to salmonella ser paratyphi a with a 99. 5% confidence level. It should be noted that, when an identification of shigella / salmonella is made by vitek 2 gn id cards, an analysis message of "confirm by serological tests" is given on the lab report. The investigation concluded this is an atypical strain for the vitek 2 gn knowledge base.
 
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Brand NameVITEK® 2 GN TEST KIT
Type of DeviceVITEK® 2 GN TEST KIT
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 Key5851698
MDR Text Key51841730
Report Number1950204-2016-00086
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962609
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 07/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/05/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/19/2017
Device Catalogue Number21341
Device Lot Number241374840
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 Received07/08/2016
Was Device Evaluated by Manufacturer? No
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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