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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE (GN) TEST KIT

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BIOMERIEUX, INC VITEK® 2 GRAM NEGATIVE (GN) TEST KIT Back to Search Results
Catalog Number 21341
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
A customer in (b)(6) notified biomérieux of discrepant results associated with vitek® 2 gram negative (gn) test kit related to misidentification of an organism. The customer reported that results identified bordetella hinzii instead of bordetella avinum. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. An internal biomérieux investigation will be initiated.
 
Manufacturer Narrative
An internal investigation was conducted for a misidentification of an aql survey sample #87 of bordetella avium as bordetella hinzi from the vitek® 2 gn card. The strain and raw data were not submitted from the customer. Bordetella avium is not a species claimed by the vitek® 2 gn card. The following limitation is stated in the vitek® 2 product labeling concerning the testing of unclaimed species: "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. " the investigation concluded that the vitek® 2 gn card performed as intended.
 
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Brand NameVITEK® 2 GRAM NEGATIVE (GN) TEST KIT
Type of DeviceVITEK® 2 GRAM NEGATIVE (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
st. louis, MO 63042
MDR Report Key6267256
MDR Text Key65458116
Report Number1950204-2017-00023
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
CL 1 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 03/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2017
Device Catalogue Number21341
Device Lot Number241367110
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 Received02/21/2017
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?
Type of Device Usage

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