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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 NH TEST CARD VITEK® 2 NH TEST CARD,

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BIOMERIEUX, INC VITEK® 2 NH TEST CARD VITEK® 2 NH TEST CARD, Back to Search Results
Model Number 21346
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
This report was initially submitted following notification that a customer in (b)(6)contacted biomérieux to report a misidentification of campylobacter jejuni ssp jejuni atcc® 33560¿ as campylobacter coli in association with the vitek® 2 neisseria-haemophilus (nh) identification (id) test kit. Investigational testing was performed using two atcc® 33560¿ strains (s1 and s2) submitted by the customer, as well as the internal biomérieux atcc® 33560¿ strain (s3). It should be noted that this atcc® strain is not a qc strain intended for the nh id card. Investigational testing included: vitek® ms: obtained identification to campylobacter jejuni for all three atcc® strains. Vitek® 2 nh id (customer lot 2450185403): s1 - excellent identification to campylobacter coli. S2 - low discrimination between campylobacter coli and c. Jejuni ssp jejuni. S3 - excellent identification to campylobacter coli. Vitek® 2 nh id (random lot 245398920): s1 - excellent identification to campylobacter coli. S2 - low discrimination between c. Coli, c. Jejuni ssp jejuni and c. Fetus ssp fetus. S3 - excellent identification to campylobacter coli. The investigation reproduced the customer result 67% of the time. The investigation concluded campylobacter jejuni ssp jejuni atcc® 33560¿ is an atypical strain for testing via the vitek® 2 nh id card. As previously noted, this atcc® strain is not a qc strain intended for the nh id card.
 
Event Description
A customer in (b)(6) notified biomérieux of a discrepant result associated with vitek® 2 neisseria-haemophilus identification card (nh) (reference (b)(4)). The customer performed two methods : they used the strain after 24-48 hours of incubation and after 48 hours of incubation. For each incubation, the results of the atcc strain were non-conforming. The result obtained was campylobacter coli instead of campylobacter jejuni. There is no indication or report from the hospital to biomérieux that the discrepant result led to any adverse event related to a patient's state of health. The strain in question is an internal quality control sample. An internal biomérieux investigation will be initiated.
 
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Brand NameVITEK® 2 NH TEST CARD
Type of DeviceVITEK® 2 NH TEST CARD,
Manufacturer (Section D)
BIOMERIEUX, INC
595 anglum road
saint louis MO 63042
Manufacturer (Section G)
BIOMERIEUX, INC
595 anglum road
saint louis MO 63042
Manufacturer Contact
ellen weltmer
595 anglum road
saint louis, MO 
FR  
MDR Report Key6500097
MDR Text Key247108299
Report Number1950204-2017-00122
Device Sequence Number1
Product Code JTO
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K842587
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 08/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/30/2018
Device Model Number21346
Device Lot Number2450185403
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 Received08/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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