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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 from (b)(6) reported to biomérieux a misidentification of klebsiella pneumoniae as klebsiella oxytoca (99%) in association with the vitek® 2 gn test kit. The isolate was tested with the filmarray® and was identified as klebsiella pneumonia, while testing with the vitek®2 gn identified klebsiella oxytoca. The customer reported there was no impact to the patient. The isolate was requested from the customer. An internal biomérieux investigation has been initiated.
 
Manufacturer Narrative
An internal biomérieux investigation concluded the following: the submitted isolate was subcultured and testing included gn cards from the customer's lot and a random lot, in duplicate. Also tested was the api 20e test kit. All four gn cards tested resulted in excellent identifications of klebsiella pneumoniae. The api 20e gave a low discrimination identification of k. Pneumoniae 1/ k. Pneumoniae 2. Vitek 2 gn cards are performing as expected. A review of the customer's k. Oxytoca data (analysis time of 2 hours) against the expected reactions for k. Pneumoniae demonstrated 1 atypical positive reaction (iarl) contributing to 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
st. louis, MO 63042
3147317301
MDR Report Key6230884
MDR Text Key64128846
Report Number1950204-2017-00005
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeCO
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 04/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/07/2017
Device Catalogue Number21341
Device Lot Number241385810
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 Received03/07/2017
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

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